Regulatory Associate Resume Sample
Camron O'Connell
68125 Jacobi Common,
San Francisco,
CA
+1 (555) 145 1151
Work Experience
Regulatory Associate
03/2018
-
PRESENT
San Francisco, CA
- Guide and influence development team and function regarding internal and Agency registration management processes and requirements
- Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate
- The IND and NDA submissions
- Tracking the status of pending applications and commitments
- Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of the Agency’s internal process and requirements to optimize the application presentation to facilitate review
- Generate reports to evaluate a variety of metrics related to the review and approval of materials through CRC and PMRC. Provide Material owners with expiration reports to ensure all materials are scheduled for a timely annual review prior to expiration and retirement from use
- Coordinates and facilitates Clinical Research Coordinator and Institute Review Board (IRB) submissions, including initial submissions, amendments, Informed Consent Form (ICF) changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance
- Enters study information and ensuring accuracy of information in Oncore
Senior Regulatory Associate
11/2014
-
02/2018
Dallas, TX
- Communicates with investigators and research staff (study team) throughout the various stages of the study life cycles
- Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments
- Creates and makes revisions to informed consent and HIPAA forms
- Agile minded regulator with a passion for Cosmetic and Medical Device New Product Development
- Previous experience in EU non-licensed (and medicinal) strategy, Product Information (PIF) and Medical Device Technical File generation
- Provide legal and technical support to Consumer Helpline, Customers, Sales and Marketing and local market nutritionists
- Coordinates and facilitates CRC and IRB submissions – for example, initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance
Regulatory Associate Manager
12/2011
-
09/2014
Phoenix, AZ
- Enters study information and ensures accuracy of information in Oncore
- Creates and revises informed consent and HIPAA forms
- Maintains essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation
- Prepares for, and participates in, sponsor monitoring visits and audits
- Relevant work experience required
- 0 – 2 years of prior experience managing interns and/or external consultants
- Regulatory experience in the field of Medical Devices
- Able to work autonomously & provide independent opinions
Education
Clark University
2005 - 2010
Bachelor's Degree in Chemistry
Professional Skills
- Strong negotiating, influencing and interpersonal skills
- Excellent organization skills are mandatory, in addition to being detail oriented
- Detail oriented, accurate and excellent record keeping skills
- Excellent regulatory, technical, and problems solving skills
- Strong presentation skills and ability to explain technical subjects to a non-technical audience
- Proven experience in working with Testing Authorities in negotiation of Product Specifications
- Proven experience in working with SFDA
How to write Regulatory Associate Resume
Regulatory Associate role is responsible for organizational, research, planning, administrative, organization, printing, finance, training, integration, database.
To write great resume for regulatory associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Associate Resume
The section contact information is important in your regulatory associate 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 Associate Resume
The section work experience is an essential part of your regulatory associate 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 associate 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 associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Associate resume experience can include:
- Attention to detail, problem solving skills and negotiation skills needed. Ability to handle complexity
- Effectively interacts with the regulators to ensure expectations are met throughout the examination process
- Experience in preparing and submitting dossiers, managing regulatory requirements
- Proven track record in delivering projects on time in a high pressure environment
- Develops a good understanding of Key’s organization and products and related regulations
- Transform solid thinking into action
Education on a Regulatory Associate Resume
Make sure to make education a priority on your regulatory associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory associate 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 Associate Resume
When listing skills on your regulatory associate 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 associate skills:
- Operate effectively in faced paced environment
- Project management skills including planning and tracking
- Interacts effectively with functional business units to obtain documentation required for sub-missions
- Understand and interpret directives and regulatory guidelines and communicate them effectively
- Understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders
- Working knowledge of GLP and cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices
List of Typical Experience For a Regulatory Associate Resume
1
Experience For Senior Regulatory Associate Resume
- Strong analytical and good oral and written communication skills
- Strong writing skills
- Communicate effectively orally and in writing with non-technical and technical staff
- RA experience, with recent experience of working with Medicines in a EU capacity
- Opportunity to leverage team effectiveness and performance through on-going feedback and coaching
2
Experience For Global Regulatory Associate Resume
- Experience in a law firm or government setting working with regulatory and administrative law
- Good understanding of the FMCG industry
- Builds effective communication between lines of business and regulatory agencies
- Several years of previous experience in Regulatory Affairs or food labelling background
- Min. 5 years relevant work experience required
- Experience with Food GMP's, SOP's, HACCP/Food Safety and Environmental guidelines
- Interpret, apply, and implement regulations and guidances. Share knowledge and experience with peers and cross functional team
3
Experience For Regulatory Associate Manager Resume
- Relevant work experience required
- Experience with GMP's, SOP's and Environmental guidelines
- Previous 5-7 years of experience in global submissions work
- Evaluating emerging or existing policy around NOP rulings and recommendations
- Leading role in adaptation of local MSDSs and labels texts in local language (EE level)
- Leading role in data management (archive)
- Coordinating with Danone North America’s Public Affairs team on OTA and other relevant trade association activities
4
Experience For Legal & Regulatory Associate Resume
- Guiding business on complex issues with Organic, Non-GMO and Kosher
- Assessing and communicating to the business on best practices for certifications
- Responsible for the all-electronic and paper assembly, publishing, production, dispatch, logging and archiving of regulatory submissions
- Actively contribute to the activity of high performing local teams, including looking for ways to improve the performance,
- Responsible for assisting regulatory team members in identifying and reviewing technical documentation in preparation for product registration packages
- Review product labeling and supporting materials
- Assist in the coordination of product labeling revisions for marketing outside the United States
5
Experience For Scientific & Regulatory Associate Resume
- Maintain certifications and related documentation up to date, liaising with Sourcing and other cross-functional teams as appropriate
- Maintain regulatory databases by regularly updating information for completeness and ensuring correctness
- Assist Manager, RA in planning deficiency response strategies’ and coordinate with all stake holders in preparing for deficiency responses
- Ensure maintenance and compliance of existing H&H/Detergent products with local requirements during the product lifecycle
- Provide regulatory support and consultancy to internal and external customers in a business oriented way (including induction, training, etc.)
- Monitors the line of business’ timely delivery of commitments during the exam
- Communicates with regulators and line of business personnel to resolve potential issues during the examination process
- Identifies training and other needs for regulatory examiners and coordinates the delivery of these items needed for examiners to conduct their examinations
- Maintains supervisory correspondence, regulatory inquiries and responses and meeting information
6
Experience For Capital Markets Regulatory Associate Resume
- 5. Classify ingredients according to relevanthazcom regulations
- Regulatory Tasks: Compiling RegulatoryNotifications and Preparation of Regulatory Documents
- Responsible for monitoring inventory of supplies related to submission preparation and initiate purchase orders
- Establish and facilitate document management activities at UBC and with clients that are required to support timely and accurate electronic publishing
- Shared responsibility for the Label Review and Approval process for product labels. Maintain database and process for secondary packaging labels
7
Experience For Legal, Consumer Regulatory, Associate / VP Resume
- Gain Understanding of Legislative and Regulatory Climate
- Establish close communications and working relationship with cross functional teams to meet business objectives
- Manage registration tracking table
- Internal control/supervision of received/ongoing registration documents received from registration bodies
- Assist with review of labeling and clinical reports for regulatory compliance
8
Experience For Regulatory Associate Director Resume
- Provide the business clear timing and cost estimates for certifications
- Basic understanding of US regulations and export needs
- Self-directed with ability to bring projects to completion
- Versatility - multi-tasking (ability tohandle many different tasks simultaneously)
- 11. Workingknowledge of various word processing and graphic software packages
- Manage and develop team to ensure team activities are delivered in full and on time
- Independently manages the examination process through a consistent approach
9
Experience For Product Regulatory Associate Resume
- Assists in the development and documentation of a regulatory examination program
- Actively facilities examination-related meetings
- Proactively provides direction and assistance to line of business personnel and others on best practices as it relates to the examination process
- Provides regular status updates to individuals involved in the exam
- Attends periodic meetings with the central point of contact for each agency to maintain open communication with the regulators
- Prepares periodic reports related to status of examinations and MRIAs and MRAs
- Suggests and assists in the development of enhancements in department processes and procedures to increase efficiency and/or improve service provided internally and externally
10
Experience For Junior Regulatory Associate Resume
- Identifies and/or develops tools to support a consistent examination approach, and instructs lines of business on their use during the examination process
- Provides consistent updates and escalates potential issues to Regulatory Liaison on a timely basis
- Providing nutritional calculations for all cereal and snacks projects, advising Food Technologists how recipe changes impact a product’s nutrition profile with particular focus on a business transformational project
- Supporting the routine analytical monitoring programme for Kellogg Cereal and Snacks products. Analyzing testing reports with Kellogg Plants to capture trends and agree corrective action plans
- Administers the coordination and facilitation of Council on Research & Creativity (CRC) and Institutional Review Board (IRB) submissions, including initial submissions, amendments, Informed Consent Form (ICF) changes, progress reports, continuing reviews, and deviations - while ensuring regulatory compliance
- Medical device experience in a regulatory compliance role
- Shown experience in interactions with regulatory bodies
- Related work experience
- Creates and revises the informed consent and HIPAA forms
List of Typical Skills For a Regulatory Associate Resume
1
Skills For Senior Regulatory Associate Resume
- Very strong organizational skills that is necessary to manage and multi-task various activities
- Detail oriented with strong communication and organizational skills
- Good computer skills. Eg. Microsoft office, adobe professional, etc
- Masterful communication, organizational, negotiation and interpersonal skills
- Strong regulatory strategy experience
- Proven experience in the China medical industry
2
Skills For Global Regulatory Associate Resume
- Impactful verbal and written communication skills
- Assist Regulatory Director with review of resubmitted pieces, ensuring requested revisions have been implemented prior to production
- Experience working cross-functionally and as part of diverse teams
- A problem solver who likes the challenge of working with multiple priorities
- Demonstrated understanding of RB IFCN internal processes
- Experience in working with RB IFCN databases
- Experience managing ingredient technical specifications
3
Skills For Regulatory Associate Manager Resume
- Experience using product life-cycle management systems
- Regulatory and Quality experience
- Previous experience with high level interaction with Testing Centers and SFDA
- Pharmaceutical regulatory affairs experience
- B.Sc. with 2-4 years of experience in a relevant scientific discipline (e.g., Toxicology or related field)
- Experience with either EPA or FDA registered products is required
4
Skills For Legal & Regulatory Associate Resume
- Work experience in the financial services or other highly regulated industry
- Work experience in a compliance function in the financial services industry
- European and/or Global regulatory experience
- Full product lifecycle experience
- Experience in a CAP/CLIA, GxP-regulated environment
- Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy
- Experience w/ compliance & labeling review/approval (food)
- Experience preparing regulatory dossiers
5
Skills For Scientific & Regulatory Associate Resume
- Interpret, apply, and implement regulations and guidance (consumer goods – cleaning products)
- Regulatory Oncology experience
- Apply gained knowledge and experience to increasingly complex regulatory issues
- Interpret, apply, and implement regulations and guidance. Share knowledge and experience with peers and cross functional team
- Managing licencing and post marketing activities for all medicinal products marketed globally
- Collecting, collating and evaluating data for routine internal and customer regulatory reports
- Working knowledge of applicable regulations and guidances including current Office of Generic Drugs submission requirements, ICH, cGMP, etc
- Being part of a wider project team supporting a new product launch from a regulatory view point
6
Skills For Capital Markets Regulatory Associate Resume
- Tracking and maintaining licenses and company submissions as required by applicable regulatory agencies
- Keeping abreast of local and international legislation, guidelines and customer practices in all countries that the company is exporting to
- Advising and training employees on regulatory requirements
- Participating as an inspection team member during regulatory inspections
- Tracking of and participating in communications with regulatory authorities
- Acting in compliance with Poland’s pharmaceutical law, ICH-GCP, EU directives and in line with local and global procedures
- Meeting deadlines and enable to coop with complex tasks,
- Working knowledge of FDA regulations, USDA National Organic Program and NSF/ANSI 305
7
Skills For Legal, Consumer Regulatory, Associate / VP Resume
- Working knowledge of ANDA, and post-approval submission requirements and guidelines
- Working with multiple functions and external stakeholders across the medicines category
- Reporting into Regulatory Category Lead
- Maintaining regulatory submission accounts
- Developing the ‘side panel’ product information for all Kellogg’s products ensuring legal compliance for the European business
- Preparing submissions of license applications and renewals
- Support Regulatory Affairs, Advertising and Promotion team by conducting Regulatory specific research, including FDA/OPDP enforcement precedent
- Be a “go to” person for internal and external regulation interpretation, for purposes of guiding product specifications, packaging, and client consultations
8
Skills For Regulatory Associate Director Resume
- Draft and review some document content (depending on level of regulatory knowledge/expertise)
- Works to develop and modify methods/techniques for solving problems
- Coordinates activities pertaining to the compilation and submission of original IND/IDE applications and MFs for management and stakeholder review
- Reviews and/or assists with project development updates, standard operating procedures, and work instructions for regulatory processes
- Coordination of scheduling required regulatory MIT
- Compilation of all MIT results and reporting to responsible parties
- Maintain regulatory compliance work and coordinate weekly meeting to communicate
- Manage the Market Risk Limit Letter structure and ensure alignment to the General Ledger and associated management reporting
9
Skills For Product Regulatory Associate Resume
- Manage other regulatory reference data, including Regulation W and YY
- Support the resolution of discrepancies/exceptions escalating to management as required
- Knowledge of food composition as it relates to food labeling and dietary supplements
- Flexibility to work with counterparts at all levels of the organization, including Senior Leadership
- Comfortable with labeling databases, computer software and systems
- Support the export regulatory process by working closely with quality to review & provide markets feedback on requested information
10
Skills For Junior Regulatory Associate Resume
- Supports planning council process for export market product requests
- Authors or updates standard operating procedures and work instructions
- Basic understanding of regulated product environment and functions
- Decision Making: Ability to make decisions which have impact on the department’s credibility, operations, and services
- Over 2 years of Regulatory Position dealing with medical devices or related field
- Familiarity with well tracking tools
- Comfortable with ambiguity and problem solving
- ECTD submissions and SPLs using software
- Deliver projects and other initiatives to progress current product portfolio by providing CMC-related direction and support to stakeholders
List of Typical Responsibilities For a Regulatory Associate Resume
1
Responsibilities For Senior Regulatory Associate Resume
- Excellent verbal, comprehension and writing skills required
- Develop working knowledge of Avid Radiopharmaceuticals’ manufacturing and analytical procedures and method validations
- Preparing FDA, EU, APAC product submissions required
- Develop a thorough understanding of Avid’s Chemistry, Manufacturing, and Controls (CMC) regulatory filings and manufacturing and analytical procedures
- Review product labeling, advertising, promotional materials against supporting documentation
- Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance,
- Gather input from business partners regarding safety, labelling, communications and PR related issues
- With input from business partners provide Strategic Regulatory advice to Category Development regarding safety, labelling, communications and PR related issues
- Understand of marketing strategy and planning issues
2
Responsibilities For Global Regulatory Associate Resume
- Familiarity with factors likely to influence the regulatory environment, including new and emerging
- Work together with other functions (eg, marketing, supply chain) to deliver NPD and value engineering projects,
- Apply knowledge gained regarding medical device/IVD regulations of FDA and International regulations (including EU)
- Assist in writing Avid’s CMC regulatory documents
- Educate teams regarding regulatory submissions procedures
- Attend trade association/Regulatory Agency meetings and represent company interests with key government agencies while remaining competitive
- 3) Compilation and publishing of company submissions (for partnered and/or 3rd party manufactured projects)
- 6) Search FDA databases to determine existing completion for proposed new projects
- Ensure compliance with existing products
3
Responsibilities For Regulatory Associate Manager Resume
- Monitor and communicate with business partners regarding regulatory issues
- Generate regulatory documentation e.g regulatory strategy using guidelines such as International Nomenclature of Cosmetic Ingredients (INCI)
- Work collaboratively with Regulatory Compliance and Post Approval Maintenance (PAM) groups to assist with compliance for existing products
- Result-oriented, entrepreneurial and self-motivating
- Commercial understanding of operational business issues
- Manage, execute and coordinate new MAA applications and product lifecycle maintenance activities (including variations, renewals and safety updates)
- Responsible for processing and submission of safety reports to the IRB
4
Responsibilities For Legal & Regulatory Associate Resume
- Assist in the maintenance of regulatory approval and tracking documents
- Additional worked hours above and beyond 20 hr/weekwill be compensated at the agreed hourly rate but hours worked cannot exceed 40 hr/week
- To critically review relevant information toformulate assessments and to draw scientific conclusions
- To assist in the implementation of regulatorystrategies for the pre-manufacture/pre-import notification of industrial,commercial and consumer chemicals
- To assistin the development and delivery of hazard communication advice and relateddocuments
5
Responsibilities For Scientific & Regulatory Associate Resume
- Scientific Tasks:Gather, review and interpret scientific,regulatory and/or client business-related information
- 1. Gather, review and interpret informationobtained via published and unpublished literature, from the client, fromsubcontracted testing laboratories and/or provided by project managers
- 2. Use own initiative to make sure that selectedmaterials are complete and adequately address the data gap
- 3. Summarize and extract relevant information
- 4. Keep track of reference materials
- 6. Present summarized information, or hazcomdocuments, to project manager for review
- 7. Edit documents as required based on projectmanager’s review
- 8. Address concerns and questions of the projectmanager in relation to the material accumulated on the project
- 9. Ensure timely response to all queries andthat all responses have the appropriate information and signage
6
Responsibilities For Capital Markets Regulatory Associate Resume
- 1. Learn regulatory issues related to HPA, CPR,NSNR and related government programs, accomplished through reading governmentdocuments, journal articles, assessment of government regulations and attendingworkshops and/or conferences and general communication with senior staff
- 2. Discuss and understand the notification/hazcomstrategies outlined in project proposals authored by senior staff
- 3. Work with project manager to gather requiredinformation (see above)
- 4. Review information to ensure adequacy fornotification/hazcom purposes
- 5. Compile and summarize administrative/technicalexposure-related information into the prescribed format, depending ongovernment requirements (with assistance from administrative support staff, andothers, where required)
7
Responsibilities For Legal, Consumer Regulatory, Associate / VP Resume
- 7. Edit, as required
- 1 Prepare project promotional packages, assistin the identification and distribution of necessary tasks
- 3 Remain in contact with team, e.g.,word processors, outside printing companies, etc. to ensure the scope ofwork remains focused and within the financial budget and time line allocated tothe project
- 4 Delegate final documents to word processingfor formatting and editing and delegating and coordinating copying and bindingfrom external subcontractors, where needed
- 5 At the incumbent’s discretion, delegateadministrative tasks to library and word processing (e.g., inter‑officeinquiries and maintenance of the corporate marketing, international regulatory andproject management databases)
- Influence externally where appropriate industry led regulatory reviews and initiatives of direct relevance to RB, in-line with RB’s strategic vision
8
Responsibilities For Regulatory Associate Director Resume
- Monitor developments with the NAIC, SEC, Japan FSA, State DOI’s, and CFTC as they relate to the Investment function
- Work to limit regulatory and reputational risk of Aflac and help to reinforce Aflac Global Investment’s culture
- Review submission documents for content and format corrections
- Responsible for developing and maintaining Regulatory Operations processes in compliance with health authority requirements, including regulations and guidance documents
- Consult and advise customers on regulatory submissions procedures and best practices
- Develop and manage SOP’s (Standard Operating Procedures) in order to develop standard work for the feed/pet food/pet specialty registration and regulatory processes
- Assist/Manage the stop sale process and the state sales restriction process (from the department’s view)
9
Responsibilities For Product Regulatory Associate Resume
- Create and maintain regulatory technical files
- Drive the compliance review of new ingredients and provide compliance assessments for new product support
- Provide Regulatory Support for Current Products and new product development
- Execute and provide regulatory support and input. Deliver projects and other initiatives to progress current product portfolio by providing regulatory direction and support to stakeholders
- Collect and collate data required for formulation compliance
- Prepare regulatory dossiers for FDA compliance
- Implement and execute New Regulations and Guidance
- Work with stakeholders to implement requirements within specified timelines
- Keep current with all relevant guidance. Assess and communicate all requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues
10
Responsibilities For Junior Regulatory Associate Resume
- Adjust and monitor project timelines to support the business
- Liaise with international consultants to secure compliance for new launches, maintain regulatory material and registrations up to date, and assess the impact of new regulatory changes on the business (Product safety review, ingredient statement, formatted nutrition facts panel..)
- Support Infrastructure and Systems Integration
- Provide authoritative subject matter expertise on a range of global financial regulations, supplying accurate, reliable interpretation and informed enforcement trend analysis to the Product Strategists and Sales
- Consult with clients as needed
- Author or contribute to white papers and other publishable thought leadership to bring credibility to FactSet’s regulatory brand; assist others in our group with their publications, be willing to author, co-author, and edit
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