Regulatory Affairs Coordinator Resume Sample
Eriberto Boyle
385 Thiel Spring,
Philadelphia,
PA
+1 (555) 914 0799
Work Experience
Regulatory Affairs Coordinator
09/2015
-
PRESENT
Chicago, IL
- Coordinates regulatory examinations and meetings across TCF. Works closely with TCF’s regulators and senior business line managers, including executive management. Serves as a point of contact with federal regulators during examinations
- Responsible for tracking of regulatory communications across TCF. Fulfills regulatory information requests. Works closely with executive and senior management to ensure regulatory requests are fulfilled in a timely manner
- Prepares regulatory reports for the board and management. Assists in enhancing reporting techniques and identifying alternatives for improvement
- Participates in meetings with regulators and executive and senior management and keeps records of such meetings. Facilitates meetings with regulators and senior management. Prepares and reviews regulatory meeting materials, including agendas and presentations
- Assists with the development of policies and procedures, templates and training materials to support the regulatory affairs function
- Assists with Risk Department special projects as directed
- Assists in preparing and submitting research applications and performing regulatory study start up activities, editing informed consents and other related documents, providing ongoing continuation reports to the IRB which include adverse event reporting, study amendment reporting and coordination of submissions to respective IRBs
Regulatory Affairs Coordinator, Compliance
11/2010
-
05/2015
Dallas, TX
- Assists in developing and maintaining all the site’s study and regulatory documents including study amendments, recruiting material, continual reviews and safety reports per sponsor, participating institutions, Good Clinical Practice (GCP), FDA and other applicable federal, state and local regulatory agency regulations, policies and procedures, and/or guidelines
- Supports the coordination of daily operational activities with the needs of research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors. Engage in core measures of customer service. Exhibit professional standards to ensure human subjects protection in the conduct of clinical research
- Develop and maintain all the sites study and regulatory documents including study amendments, recruiting material, continual reviews and safety reports per sponsor, participating institutions, Good Clinical Practice (GCP), FDA and other applicable federal, state and local regulatory agency regulations, policies and procedures, and/or guidelines
- Act as sites regulatory point-person to provide information to the PI, Research Director or Clinical Trial Senior Manager, and study-specific staff regarding IRB submissions and approvals of study-related documents. Maintain protocol status updates for pending and active projects. Participate in departmental meetings, conferences, and educational events
- Coordinate daily operational activities consistent with the needs of research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors. Distribute regulatory work load among Regulatory Affairs Coordinators I to efficiently accomplish regulatory efforts
- Serve as designated regulatory point-person for audits performed by regulatory agencies (i.e., OHRP, ORI, and FDA). Engage in core measures of customer service. Exhibit professional standards to ensure human subjects protection in the conduct of clinical research
- Assists in developing and maintaining all the sites study and regulatory documents including study amendments, recruiting material, continual reviews and safety reports per sponsor, participating institutions, Good Clinical Practice (GCP), FDA and other applicable federal, state and local regulatory agency regulations, policies and procedures, and/or guidelines
- Maintain various tracking logs and timelines to track regulatory submissions and approvals
- Maintain domestic and international regulatory contact list, country Health Authority requirements and project code lists
Commercial Compliance & Regulatory Affairs Coordinator
02/2006
-
08/2010
Dallas, TX
- Coordinate conference calls with Supply Chain, cross-functional teams and international affiliates
- Manage weekly team meetings and create individual objectives
- Create monthly reports for submissions and approvals
- Coordinates the process of artwork creation and approval and performs text comparisons of artwork components, including final release of Ready for Print (RfP) and approval of printed packaging material sheet (PPMS)
- Ensures optimal launch preparations for new products in close collaboration with the regulatory affairs manager (RAM), product management, local and global supply chain management (SCM) and quality assurance (QA)
- Manages translations for regulatory documents together with the assigned RAM
- Ensures appropriate archiving of regulatory relevant Swissmedic documents, including correspondence
- Establishes and maintains close professional relationship to Swissmedic (e.g. related to operational regulatory tasks) and other internal/external stakeholders and institutions, as appropriate
Education
University of California, Santa Barbara
2002 - 2006
Bachelor's Degree in Appropriate Field
Professional Skills
- Excellent verbal and written communication and interpersonal skills, superior organizational and planning skills
- Possess excellent oral and written communication skills and interpersonal skills
- Strong working knowledge of medical device regulations (21CFR) and FDA law. Excellent English skills (written and oral)
- Strong attention to detail (including proof reading skills)
- Excellent project management skills, including meeting facilitation, organization and time management
- Demonstrated communication skills and collaboration with other RA Specialists as well as other functions
- Strong computer skills with functional use of Word and Excel
How to write Regulatory Affairs Coordinator Resume
Regulatory Affairs Coordinator role is responsible for organizational, computer, software, planning, training, word, english, adobe, finance, integration.
To write great resume for regulatory affairs coordinator job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Affairs Coordinator Resume
The section contact information is important in your regulatory affairs coordinator resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Affairs Coordinator Resume
The section work experience is an essential part of your regulatory affairs coordinator resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory affairs coordinator responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory affairs coordinator position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Affairs Coordinator resume experience can include:
- Experience working with regulatory agencies is desired, preferably FDA experience and/or their global counterparts
- Independent judgment and critical-thinking skills required
- Demonstrated ability to work on deadlines, set priorities and coordinate multiple projects without compromising quality
- Time management skills; able to work to tight timelines
- Preferably experience with international submissions for IVDs, Medical Devices or Pharmaceuticals, including understanding of the registration processes
- Handles day to day work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change
Education on a Regulatory Affairs Coordinator Resume
Make sure to make education a priority on your regulatory affairs coordinator resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory affairs coordinator experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Affairs Coordinator Resume
When listing skills on your regulatory affairs coordinator resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory affairs coordinator skills:
- Strong communication skills (interpersonal, written and oral) and negotiating skills
- Excellent verbal and written communication and interpersonal skills and superior organizational and planning skills
- Documentation and record keeping skills
- Project Management experience required with background in Regulatory Affairs or Supply Chain with a strong track record of problem solving
- Experience in working/navigating within larger cross-cultural contexts and in cross-functional teams is an advantage
- Experience in writing and compiling regulatory documents, to include informed consents
List of Typical Experience For a Regulatory Affairs Coordinator Resume
1
Experience For Dach Regulatory Affairs Coordinator Resume
- Or more of CMC experience and therapeutic experience in respiratory, immunology and/or oncology
- Basic computer skills (MS Word, MS Excel, MS Power Point, Adobe and Acrobat) is required
- Preform good quality documentations including change control, Field Action, CAPAs, and Supplier/ Distributor Checklist…etc
- Is obligated to report any Adverse Event or Technical Quality Complaint in accordance to the valid local SOPs
- Regulatory Affairs experience in a medical device development and manufacturing environment required
- Regulatory experience in the biotech/pharmaceutical industry
- Two years of experience in the field of regulatory documentation management or clinical research
2
Experience For Regulatory Affairs Coordinator, Compliance Resume
- One year of clinical and/or research experience
- One or more years of regulatory experience
- Organizes and prioritizes numerous tasks and completes them under time constraints
- Assisting with assembling and filing documentation to support worldwide registrations
- Working with Regulatory Country Lead, Liaise with clinical research project managers to seek to understand clinical research program
- Willing to travel to DC and Baltimore regions as needed
- Ensuring requested changes from reviewers is implemented by initiators as requested
3
Experience For Research Regulatory Affairs Coordinator Resume
- Maintaining monthly metrics for RA/QA and coordinates with cross functional associates that provide inputs into the meetings
- Oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support
- Provides general/miscellaneous administrative support (copying, mailing, filing, organization, etc.) to the Regulatory Affairs and Corporate Services teams
- Contact the BoH by elaborating documents, e-mails, phone contacts and meetings for following-up processes of registration approval
- Assists in monitoring and reporting submission timelines
4
Experience For Commercial Compliance & Regulatory Affairs Coordinator Resume
- Preform regular review for Organizational Charts, Training Plan according to internal requirements
- Advise other Cook functional units (engineering, marketing, etc.) of the requirements in each target market as directed by the RA Specialist
- Maintains regulatory databases/filing of regulatory documentation including: regulatory strategies, change notifications and responses, letters-to-file, etc
- Maintains various internal systems and databases, including product shipment database, distributor database and various registration and licensing databases
- Support labelling activities related with harmonized packaging materials for the region
- Provides regulatory assessments to internal local and global business partners regarding quality changes and artwork requirements
- Supports integration and re-organizations affecting organizational structures and/or product portfolio as appropriate
- Contribute to process improvements and participate in the creation of process descriptions, performs assessments on guidance’s (local/global SOP, WP, HA regulations) and the on-boarding process for new colleagues
5
Experience For Cpdm Regulatory Affairs Coordinator Resume
- Ensure proper handling of deviations and CAPA handling regarding RA related compliance issues
- Monitors national changes by continuing education related to regulatory issues, which are likely to affect Novartis’ interests, and communicates these to local and global teams and management as appropriate
- Responsible for ordering department supplies and purchase orders for the department
- Assure all site documents including SOPs and administrative files are maintained in audit-ready condition
- Assist in obtaining initial documents for clinical trial procurement and site selection
- The ability to communicate clearly in writing and verbally at all levels and with all departments within and outside of the organization
- Current working knowledge of Microsoft Word, Excel, PowerPoint & Outlook
- Collaborates with the Clinical Functional Unit on projects requiring the collection of clinical data
- Responsible for regulatory submissions at one or more of the following levels
6
Experience For Federal Regulatory Affairs Coordinator Resume
- Oversee consulting firms or Technical Directors to ensure adequate services
- Represent regulatory/compliance within project teams and ongoing operations
- Review overall structure, and requirements of each protocol to determine the regulatory requirements of the project and the following
- Notify the IRB of the study's completion, according to IRB procedure
- Define the size of the organization this job is responsible for, as well as the level of the positions reporting into this job
7
Experience For UK Regulatory Affairs Coordinator Resume
- Conduct routine follow-up with sites to ensure issues are resolved and outstanding documentation is completed
- Ensure accurate and timely completion of maintenance of internal systems and tracking tools with site and study information
- This includes inputting key dates, documents and applicable information into the CTMS (Clinical Trial Management System)
- Up to 10% travel depending on business needs
- Possess a thorough understanding of the market regulatory requirements, as well as the regulatory processes
- Complete departmental training in a timely manner to address corporate and regulatory needs
- As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation
- Provide input and assist the QA Manager regarding any QA-related activities that could impact company products and/or processes
8
Experience For Product Stewardship & Regulatory Affairs Coordinator Resume
- Capability to communicate with technical and non-technical people, having the diplomacy to say "no" when Global quality is not acceptable for release
- Assist in preparation, filing and maintenance of regulatory submissions for product approval
- Proficient in MS Office software including MS Word and MS Excel
- Intermediate to expert user of standard computer systems and software programs, including MS Office (Excel, Word, Outlook, PowerPoint
- English – fluent verbally and in writing
- Coordinate and administer the Regulatory Change Management process. Evaluate each request to ensure appropriate for department, compile all requested information, and compile summaries of International responses to various change requests, and file RA “strategies” and change control responses appropriately
- Administrates systems associated with Regulatory change management process
- Works with International Regulatory Affairs Specialists to assist with preparation of regulatory affairs documentation utilized to support various international registrations
9
Experience For Regulatory Affairs Coordinator Resume
- Works with Regulatory Affairs Specialists to assist with preparation of regulatory affairs technical files
- Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies associated with the above areas of responsibility on an as-needed basis
- Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers
- Carry out the above tasks with minimal supervision
- Regulatory Affairs Coordinator reports to Regulatory Affairs Manager
- Ensure timely submission of these documents by bringing to management’s attention any problems, discrepancies and by offering any alternative solutions or more efficient workflow processes
- Supervise the processing of document entry into the client’s document systems in a timely and efficient manner to guarantee confidentiality and accuracy for use in future submissions, in the event of an inspection by regulatory authorities, or during internal audits
- Participates in Department’s initiatives to support the implementation of corporate quality goals and action plans
- Supports the FHP Regulatory Affairs Department’s collaboration with the FMCNA Compliance and Corporate Law Departments to facilitate the development and implementation of programs, policies and procedures based on best practices and regulatory requirements
10
Experience For Dach Regulatory Affairs Coordinator Resume
- Develop and maintain Early Clinical Research regulatory and Trial Master File Documents
- Perform internal quality assurance audits and report results to supervisor
- Responsible for submitting appropriate study updates to the IRB, ensuring IRB possesses the most updated status of trials conducted at DCR, serving as primary liaison between DCR and the IRB
- Prepare and maintain research project submissions per institutional and regulatory standards
- Coordinates regulatory activities for multiple clinical research projects
- Prepare regulatory binders for study team use and conduct periodic document quality check
List of Typical Skills For a Regulatory Affairs Coordinator Resume
1
Skills For Dach Regulatory Affairs Coordinator Resume
- Strong communication and interpersonal skills and able to collaborate well within RA as well across departments
- Strong ability to communicate effectively in English (both written and verbal)
- Excellent written and verbal communication, and the ability to communicate effectively with all levels of the organization
- Project management and strong organizational skills
- Computer skills to track and monitor regulatory activities
2
Skills For Regulatory Affairs Coordinator, Compliance Resume
- Experience: 3+ years research and/or regulatory experience
- Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
- Experience: One or more years of clinical and/or research experience
- Demonstrated ability to manage multiple responsibilities and priorities in a fast-paced environment under strict deadlines
- Effectively present information and respond to questions from groups of peers, customers and management
3
Skills For Research Regulatory Affairs Coordinator Resume
- Prior experience in regulatory affairs or compliance
- Experience working with NCI, Industry, and Investigator Initiated clinical trials
- Basic understanding of research specific to Human Subject Research protection, Good Clinical Practice and IRB requirements
- Excellent understanding and execution of GMP and BPL
- Pharmaceutical industry work experience
- Experience working in ICH/GCP environment Familiar with HIPAA guidelines
- Prioritize and lead multiple projects, procedures and processes by having a comprehensive knowledge of SOPs, ICH-GCP and regulations
4
Skills For Commercial Compliance & Regulatory Affairs Coordinator Resume
- Previous experience in the pharmaceutical industry, in Regulatory Affairs (global, regional or local)
- Good follow-through/diligence for task completion
- A continuous improvement mindset, and experience with development of IT systems
- Three (3) or more years of experience in Regulatory Affairs
- Good relationships with government authorities and internal stakeholders
- Strong knowledge of Quality Management Systems, and other various international regulations
- Experience with device submissions in America’s regions highly desired
- Experience in medical device or pharmaceutical industry highly desired
- Regulatory experience
5
Skills For Cpdm Regulatory Affairs Coordinator Resume
- Set and make clear priorities
- +3 / -5 years of regulatory experience, preferably in OTC areas
- Experience in registration of products in Argentina
- Experience with OTC in Pharmaceutical Industry
- Related administrative experience
- Experience in a related regulated industry
6
Skills For Federal Regulatory Affairs Coordinator Resume
- Knowledge of Medical Device Quality Systems and Good Documentation Practices
- Professional experience in a regulated industry or a technical field
- Direct regulatory experience with government agencies and product approval responsibility
- Experience in chemical regulation (CCA, K-REACH, K-BPR) is an advantage
- Two to three years of direct protocol development and regulatory submission experience, preferably in an academic environment
- Follow standard operating procedures, good clinical practice and sponsor instructions / specifications
- Strong attention to detail; a results oriented team player
- Strong knowledge of Microsoft Office: Word, Excel, PowerPoint and Adobe Acrobat
7
Skills For UK Regulatory Affairs Coordinator Resume
- Maintains an excellent understanding of global medical device regulations
- Experience interacting with ANMAT and Regulatory bodies in Uruguay and Paraguay
- Understanding of research standard as set forth by FDA, OHRP, UCH, UCD and NCI
- Understanding of the pharmaceutical environment, regulatory affairs, procedures and requirements
- Coordinating of the centralized management of regulatory submissions in Argentina
- Performing personal follow up with Health Authorities
- Understanding of international regulatory requirements
- Provide support in assigned Global Regulatory Teams, ensuring the best regional contribution for the GRPS and following the Blueprint process
8
Skills For Product Stewardship & Regulatory Affairs Coordinator Resume
- Proficiency in word processing, database maintenance and filing
- Coordinate and support efforts in compiling and preparing hardcopy and electronic information packages for submission to regulatory agencies
- Promotes compliance with Merck policies, local and international regulations regarding Drug products Marketing Authorizations and GMP
- Provides continued support and feedback to local Marketing, Headquarters and GRACS regarding status and/or issues
- Ensures staff and investigator training and licenses are current: CITI, HIPAA, GCP training
- Microsoft Office knowledge, including Excel, Word, and PowerPoint
- Completes and submits continuing reviews, amendments, and other protocol-specific documents
9
Skills For Regulatory Affairs Coordinator Resume
- Support the development and implementation of a Regulatory Strategy for assigned projects, including its risk mitigation plans, as applicable
- Support the preparation of the dossiers (briefing package, slide kit) for pre-submission meetings, as requested
- Knowledge of local regulations , stories of Como: LGS , RIS, NOM 072, 073 NOM , NOM 059 , LGS on advertising , agreements by COFEPRIS
- Continuous tracking of own and others activities
- Fluent English speaking, oral and written expression and comprehension
- Computer proficiency in word processing and Excel required
- Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked Changes functionality required
10
Skills For Dach Regulatory Affairs Coordinator Resume
- Proficient at monitoring multiple activities simultaneously with attention to detail
- Proficient in using Microsoft Word, Access, Excel and Outlook
- Decision-making on the appropriate strategies for fast approval at IRB/EC/MoH level
- Creates requisitions using the SAP and eBuy+ systems
- Exercises judgment in the retention, routing and destruction of data and confidential data
- Assemble documentation to support in-country agents and distributors in registering Spacelabs' products worldwide
- Writes clear and accurate consent/ HIPAA documents
- Completes consents, applications and other required forms as per the applicable Institutional Review Board (IRB)
List of Typical Responsibilities For a Regulatory Affairs Coordinator Resume
1
Responsibilities For Dach Regulatory Affairs Coordinator Resume
- Provide on-the-job training, set priorities and schedule workflow required to support project objectives
- Review and validate the translation to Spanish version sent by Area and made locally in the affiliate
- Working on various projects as directed by RA Specialists
- Coordinating document legalization or apostille
- Requesting Certificates to Foreign Government or other similar certificates
2
Responsibilities For Regulatory Affairs Coordinator, Compliance Resume
- Evaluating Customer Service order for product approval verification purposes
- Advise other cross functional teams (quality, engineering, marketing ) of the requirements in each target market as directed by the RA Specialist
- Support bidding processes by providing updated regulatory documents
- Assist in producing new or revised global medical device submissions in the format consistent with the governing SOP's
- Provide administrative support to monitoring of regulatory submission timelines and meeting minutes
3
Responsibilities For Research Regulatory Affairs Coordinator Resume
- Work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment
- Coordinates and assures a timely review and approval of the Artworks for packaging materials for all products
- Maintain the GMP's of manufacturing sites issued by Cofepris updated,
- Assists in the submission and archival of advertising and promotional items
- Maintains up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
- Assist Regulatory Affairs function, through the following activities
- Interfacing with various departments to collect and organize required documentation materials
- Provide Regulatory Affairs support to Strategic Manufacturing under supervision
- Maintains Technical Documentation to support CE Marking of MMS products
4
Responsibilities For Commercial Compliance & Regulatory Affairs Coordinator Resume
- Manage all Certificate of Pharmaceutical Product (CPP) requests including needed legalizations
- Provide own transportation to attend meetings within the service area or at training locations
- Compile research protocol documents and all materials required for regulatory submissions in compliance with institutional and federal policies
- Develop the consent form, HIPAA authorization form, and other IRB-required forms specific to each protocol
- Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions
- Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership
- Maintains current and accurate documentation in the regulatory binders (paper or electronic) as required by regulations and sponsors
- Participates in required teleconferences, on site meetings and off site investigator meetings, as required
5
Responsibilities For Cpdm Regulatory Affairs Coordinator Resume
- Coordinate and assist in the preparation, compilation and submission of Regulatory documentation according to applicable FDA regulations and guidance. Track commitments and outstanding issues with Regulatory and governmental authorities
- Assist in the review of product labeling and artwork including claims for Colgate oral care, personal care, home care and Tom’s of Maine products. Participate in Regulatory Affairs at Claims Tracker meetings for assigned products
- Maintain and coordinate general regulatory documentation, including the Regulatory file room and archives. Maintain paper and electronic files and information management databases, and ensure the availability of an up to date inventory. Update Regulatory databases in order to have information readily available and easily accessible
- Assist in the development and update of Standard Operating Procedures (SOPs) and/or Current Best Practices, as required. Identify improvements and efficiencies to RA department systems and processes. Manage other departmental operational and administrative requirements, as needed
- Coordinate with Global Legal Organization representative to ensure that all Colgate Total documentation submitted to the FDA are properly scanned and uploaded into the CP database
- Experience preparing, compiling and submitting regulatory submissions to FDA
6
Responsibilities For Federal Regulatory Affairs Coordinator Resume
- The ability to work and prioritize multiple projects and tasks
- Experience in Regulatory Affairs function or related, on a Transnational CPG Company
- Coordinate and prepare moderately complex regulatory submissions and documentation required for worldwide registration/licensure of products outside the U.S
- Maintain a system to assure that all international product registration is current and that registrations are up-to-date to assure product is continually and legally available in each local
- Provide general support to the RA department in all regulatory-related matters
- Actively participate as the regulatory/quality representative in project, product and process meetings
- Help to ensure the effectiveness and currency of the Quality Management System, including the organization’s adherence to the Quality Manual and supporting Standard Operating Procedures
- Serves as regulatory contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records
- Supports both local and International strategic initiatives to improve local productivity and reduce cycle times primarily for the Registrations, renewals and PACs processes
7
Responsibilities For UK Regulatory Affairs Coordinator Resume
- Plans and performs a regulatory process including preparation of documents for New Registrations, Renewals and PACs submission, follow up before the Agency and notification of approval letters
- Ensures that ORION (On Line Regulatory information) database is updated with the submission/approval dates for all the records for country responsibility and aligned with the pharmaceutical information for each product
- Supports to Sales Department with Regulatory Documents (GMP certificates, Bioequivalence letters and others) for Tender Bids
- Supports the other Regulatory processes, as required by the Manager
- Develops global regulatory strategies for projects in collaboration with the Regulatory Scientist (as applicable)
- Assists with preparation of regulatory submissions for specific target markets
- Collaborates with internal or external regulatory team members
- Coordinates multiple projects at one time and provides regular reports to regulatory management
8
Responsibilities For Product Stewardship & Regulatory Affairs Coordinator Resume
- Provides support to currently marketed products as necessary
- Manage product registration and renewal process across MERCOSUR countries in a timely manner
- Represent represent Clorox at local Chambers/Trade Associations, in order to be aware of new regulations and assure Clorox position is considered
- Graduates of Pharmacy, Chemist or related
- Advanced English level -- Spoken & Written
- Coordinate and oversee IRB submissions
- Communicates with sponsor on their startup needs and documentation
- Obtain necessary approval of the modified consent forms, investigators, study personnel, CV's, etc
- Prepare and maintain regulatory documents needed for new IRB submission to local or central IRB
9
Responsibilities For Regulatory Affairs Coordinator Resume
- Assist site personnel and maintain regulatory documents needed for interim submissions. Advises clinical team with all regulatory and safety support services including but not limited to trial communication and document distribution, critical document collection process, protocol deviations and safety reporting
- Oversee and facilitates the submission of the clinical study annual renewal as per the needs of the site, and the requirements of the IRB and sponsor
- Ensure that all study documentation (regulatory, IRB communications and sponsor communications are appropriately filed at the completion of the study
- Store all files in a permanent and safe location
- Tracks status of all regulatory submissions for completion
- Assists administration in the development, implementation and adherence of policies and procedures (SOPs) for regulatory documentation functions
- Fill in as a Clinical Research Coordinator as need for Baltimore Cardiology
- Ensure the dossier meets with the local requirements according to the corresponding legislation published by Cofepris; and carry out all activities required for NMC presentation
- Give a close follow up to all internal activities needed for revision & approval of all administrative & technical variations
10
Responsibilities For Dach Regulatory Affairs Coordinator Resume
- Coordinate the translation to Spanish version of the technical, legal and/or clinical support information sent by global. Ensure the appropriate translation to Spanish of clinical overviews and its validation by medical area. Prepare & integrate the complete file for the submission to Cofepris
- Develop the local texts ensuring that they meet with local regulations , & participate in the labeling process for creating new or updating previous artworks for the pharmaceutical, biotechnological & biological products, as initiator and/or reviewer
- Interaction with the local regulatory agency (Cofepris) and the following internal areas: Q.A, Marketing, Medical, Pharmacovigilance, .AA&S, Demand, Market Access, Area Regulatory etc
- Creation and assembly of submission content
- Controlling and maintaining regulatory records, including, but not limited to: submission documentation, establishment registrations, approval and clearance letters
- Maintain the Latin America part number registration tracker
- Generate Import for Export authorization and maintain records
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