Regulatory Operations Resume Sample
Prince Labadie
9952 Nikko Road,
Boston,
MA
+1 (555) 542 1631
Work Experience
Regulatory Operations Specialist
09/2015
-
PRESENT
Boston, MA
- Provides leadership and input to the development and implementation of the overall strategic direction of
- Identify opportunities for improving data quality and reducing ‘noise’ and false exceptions
- Experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, electronic publishing) or clinical environment, preferably in the biotechnology/ pharmaceutical industry or another health care industry
- Contribute to the development of the processes and procedures for all Operational functions
- Contribute to the development of systems and data associated with Regulatory Functions, process improvement, system integrations, system implementations, system development work
- Contribute to the development of robust reporting to support our Regulatory Affairs and Regulatory International teams, and executives
- Hire, manage, support and develop/train Regulatory Operation staff and secure sufficient resources to support the company’s goals and objectives
- Keeps current of regulatory submission publishing standards to ensure compliance with Regulatory Agency’s requirements
Regulatory Operations Operator
02/2011
-
06/2015
Los Angeles, CA
- Keep stakeholders up to date on progress and escalated issues, ensuring recommendations/solutions are provided where applicable
- Review, prepare and coordinate executive dashboards and program status updates on project accomplishments against milestones on both a scheduled and ad hoc basis
- Develop strategy for use of electronic document management software (EDMS) within Regulatory and all applicable departments, direct administration of the EDMS, address user requirements and upgrades for the system. Serve as primary point-of-contact
- Provide timelines to Project Teams and key Regulatory stakeholder regarding submission timelines
- Work to establish and maintain process around use of the Regulatory Information Management system, InSight Manager. Determine strategy for global use of the system and manage the entire system
- Work with vendors and various departments on multiple software projects, including new installation and upgrades, serving as the business lead and primary point-of-contact
- Participate in project team meetings and provide status updates of Regulatory Operations activities, represent the company’s Regulatory Operations group in internal and external development project meetings and contribute to the establishment of regulatory strategies for new products and processes
Product Safety & Regulatory Operations Internship
09/2004
-
01/2011
Detroit, MI
- Support business units in applying a consistent approach to first-line monitoring of controls associated with high-risk procedures (e.g., in the development of KRIs), and in applying a consistent framework to the testing of those controls (e.g., in the development of KPIs)
- Proactively address gaps, identify opportunities and lead changes for streamlining end to end processes to ensure delivery of regulatory changes
- Coordinate all regulatory self-assessments across different business lines on an ongoing basis and obtain business sign-off
- Assist with providing CB senior management with consolidated, annotated reporting on first-line monitoring and testing of high-risk controls (e.g., the Executive Steering Committee binder)
- Assist in providing consistent, consolidated, annotated reporting on additional aspects of CB’s regulatory compliance program, including emerging compliance risks, drawing on data obtained from the business units and other sources as required
- Ensure Scotiabank’s project management practices are applied to consolidate, plan, execute and govern multiple project initiatives
- Assist with resolving issues and negotiating compromises between team members/stakeholders to meet objectives, overcome obstacles and/or recommend alternatives, as required
Education
Grand View University
1999 - 2004
Bachelor's Degree in Life Sciences
Professional Skills
- Strong written and oral communication, technical writing and editing skills, leadership, interpersonal and influencing skills
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
- Excellent verbal and written communications skills, editing and organizational skills
- Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment
- Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
- Excellent project management skills are required, as is the ability to effectively manage multiple simultaneous projects
- Excellent organizational, multi-tasking, time-management skills; effective at managing many competing projects and consistent ability to fulfill commitments
How to write Regulatory Operations Resume
Regulatory Operations role is responsible for interpersonal, organizational, regulatory, analytical, advanced, technical, editing, software, basic, excel.
To write great resume for regulatory operations job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Operations Resume
The section contact information is important in your regulatory operations 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 Operations Resume
The section work experience is an essential part of your regulatory operations 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 operations 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 operations position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Operations resume experience can include:
- Work independently under general supervision, adapt to changing priorities and manage multiple tasks; good organizational and planning skills
- The ability to effectively maintain, co-ordinate and prioritise multiple tasks and projects
- Promote effective teamwork among Regulatory Operations Staff. Provide day to day direction on work and basic management and develop skills for staff
- Use skills to lead teams to achieve company goals in creative and effective ways
- Excellent communication skills, fluent in English language (written/verbal) as appropriate
- Detail-oriented, with strong communication skills with other regulatory affairs professionals and IT colleagues
Education on a Regulatory Operations Resume
Make sure to make education a priority on your regulatory operations resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory operations 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 Operations Resume
When listing skills on your regulatory operations 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 operations skills:
- Self-organizing, self-directing, highly motivated with strong critical thinking and analytical skills
- Demonstrated skills managing project timelines and organizing supporting resources
- Demonstrated analytical and problem-solving ability with demonstrated generation of alternative solutions prior to elevation of issues to management
- Proven and progressive operations experience or equivalent including experience in a customer contact, operational control or compliance function or equivalent
- Demonstrated experience in preparing 510(k) submissions for FDA, experience with Class III devices
- Excellent leadership, time management, problem solving and negotiation skills
List of Typical Experience For a Regulatory Operations Resume
1
Experience For Regulatory Operations Specialist Resume
- Review, validate, and store tax certification documents, including IRS Forms W-8 and W-9. Generate customer correspondence following receipt of invalid forms
- Basic technical writing and editing skills
- 4+years regulatory/clinical experience at a medical device company or 4+ year(s) related experience and training
- Advanced skills with submission publishing software
- Experience in stakeholder management and in building excellent professional relationships
- Prior experience in operations, compliance is nice to have
2
Experience For Regulatory Operations Manager Resume
- Planning/ Organization: · Plans and organizes non-routine tasks. · Initiates or maintains work schedule. · Establishes priorities of work assignments
- Develop a deep understanding of data quality across many of Lyft's systems, consolidating data from many disparate sources to aid future reporting
- Function as a team lead when Manager is not available prioritizing work and facilitating issue resolution or escalation
- Computer Sciences or equivalent relevant experience and training. RAC certification an asset
- Extensive experience working with current electronic standards (e.g., eCTD, SPL, CDISC)- is required
- Experience in supporting business development activities an asset
- The ability to interact with clients, to adapt to their priorities, and while providing strategic direction is essential
- Experience working with cross-functional teams
3
Experience For Manager, Regulatory Operations Resume
- Experience compiling electronic submissions
- Experience in electronic document publishing
- Experience compiling IND, NDA/BLA, and CTD submissions
- Experience using electronic document management systems
4
Experience For Regulatory Operations Operator Resume
- Strong technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology
- Demonstrable experience of working with an Agile methodology in a fast paced environment
- An analytical / logical mindset with a good approach to problem solving
- Throughout the conduct of the trial, adhere to SCRI SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines
- Experience within the medical device and/or pharmaceutical industries
- Experience in Regulatory Operations publishing or equivalent in biotech, pharma, or medical device
5
Experience For Senior Regulatory Operations Specialist Resume
- Experience with RIMs and electronic submission software
- Align cross-functional teams around requirements and priorities, determine business goals and track progress across all projects
- Lead and prioritize deep dives into team data to uncover new product and business opportunities
- Be a strong communicator no matter what the audience: drivers or colleagues
- Successfully handle conflicts and fire drills - not an uncommon experience
- Proficient experience with electronic submissions and eCTD structure with submission publishing software
- Experience in Regulatory Affairs/Regulatory Operations in the pharmaceutical/biotechnology industry
- Coach and mentor associates, provide work oversight, prioritize work and manage timelines
- Direct regulatory experience in biotechnology environment
6
Experience For Regulatory Operations Associate Resume
- Experience with electronic data management systems (EDMS) and regulatory documentation archival required
- Experience in working with Support (preferably Zendesk) and/or any offshore partner teams
- Ensure continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors
- Investigation of data validation errors and TR trade rejections and remediation of such errors and rejections where appropriate
- Partner and develop strong relationships with the RegOps team to understand and synthesize the ways in which RegOps utilizes data
- Develop strong hypotheses, independently solve problems, and share actionable insights to drive growth
- Experience in a data analytics role or equivalent
7
Experience For Regulatory Operations Supervisor Resume
- Track and report Effectiveness and Efficiency Indicators related to Regulatory Operations
- Prepare Field Action Plans, coordinate field action activities, monitor field action effectiveness, and report field actions to regulatory agencies
- Assist with validation projects as needed
- Experience in international and domestic regulatory submissions
- Experience in Regulatory Operations publishing or equivalent in biotech, pharma, or medical device
- Entering, maintaining, retrieving and reporting regulatory data from various systems and sources
- Enabling product distribution using software systems in delivering product to distribution centers and health care clinics
- Identifying and driving process improvements in the areas of regulatory publishing and product distribution
8
Experience For Senior Regulatory Operations Analyst Resume
- Assessing and preparing responses for review of inbound Request for Information (RFI’s) & Client Due Diligence Questionnaire’s (DDQ’s)
- Monitoring of daily trade files to ensure timely reporting of in scope trades to trade repository
- Liaising with counterparties to establish the reason for unpaired/unmatched trades and agreeing a resolution to the break
- Bookmarking and hyperlinking of regulatory documentation and finalisation of submissions to the Health Authorities around the world
- Preparing US FDA compliant eCopies
- Assisting in various ad hoc projects and other task as assigned
- Understanding of eCTD submission requirements
9
Experience For Director, Regulatory Operations Resume
- Working knowledge of document management systems (e.g. Agile, Documentum, Insight Publisher)
- Working knowledge of project management systems and relevant software
- Meeting arrangements and preparation
- Understanding of strategy and promotion development processes and systems, related quality requirements
- Analyzing key operational flows and impact to Possession and Control as well as Reserve Calculations
10
Experience For Director, Global Regulatory Operations Resume
- Working knowledge of FDA regulations and ICH guidances
- Project Document Processing including: Bookmarking, Hyperlinking, Identifying Issues, Initial Reg Ops Reviews
- Advanced knowledge of word processing, spreadsheet/graphing, including knowledge of Microsoft Office applications, including Word, Excel, PowerPoint
- Basic understanding of FDA regulations relating to advertising and promotion for prescription products
- Uses independent critical judgment in interpreting and applying knowledge in IRB protocol submission
- Monitor all other relevant trade files required for various Global Trade Reporting regulations and ensure that such files are being sent in a timely manner
- Comfortable working with large data sets; using data to support and guide the team’s work
- Organized and detailed oriented - able to track and juggle ongoing and wide-ranging projects
- Follow all internal standards including: Standard Operating Procedures, Guidance Documents and Policies throughout the submission life-cycle
List of Typical Skills For a Regulatory Operations Resume
1
Skills For Regulatory Operations Specialist Resume
- Have excellent analytical skills and the ability to consult and resolve issues related to data extraction, validation, report generation
- Excellent problem-solving skills and ability to work in collaborative and independent work situations with minimal supervision
- Excellent computer software skills (Microsoft Office suite)
- Proven communications, work leadership and organizational skills
- Quality focused with strong organizational skills
- Excellent communication skills (written and verbal) required. Ability to communicate clearly and concisely with EmblemHealth staff and management
2
Skills For Regulatory Operations Manager Resume
- Strong skills in people management required
- Proven ability to establish excellent working relationships with clients, peers and team members through integrity
- Fosters team work through exceptional leadership skills
- Proven regulatory generalist with a good knowledge of drug development
- Negotiate internally Cognitive Skills or Ability to
- Effectively communicate and meet deadlines
- Proven operations experience or equivalent
- Experience as an effective project manager in projects with medium to large complexity required
3
Skills For Manager, Regulatory Operations Resume
- Experience in the pharmaceutical industry with 10+ years of direct regulatory operations experience
- Direct experience in a Regulatory Operations function with experience with electronic submissions and systems
- Multi-task effectively in fast-paced environment
- Demonstrated experience with submission to the European Union
- Multi-task between projects and effectively work with staff at all levels of the company
- Computer skills to include MS Office, MS Word, Excel, PowerPoint, Adobe, Visio
- Highly-developed stakeholder management skills to ensure functional and geographical alignment
4
Skills For Regulatory Operations Operator Resume
- Prior managerial experience is desirable
- Understanding and experience in MS Office tools, Windows and general computer literacy
- Planning/Organization: · Plans and organizes non-routine tasks w/approval. · Initiates or maintains work schedule. · Establishes priorities of work assignments
- Working knowledge and training of the regulatory requirements for licensing biopharmaceuticals with experience in regulatory writing
- Experience in managing, training and mentoring employees
- + Experience publishing eCTD using electronic publishing system and tools
- Strong understanding of manufacturing and/or distribution and auditing processes
- Good understanding of current regulatory legislation, guidelines and trends relating to submission management (process, tools, standards)
- Experience managing direct reports and advocating on their behalf
5
Skills For Senior Regulatory Operations Specialist Resume
- Experience developing and implementing new process associated with program or policy creation
- Relevant experience implementing and using electronic document management systems
- Experience writing and assembling technical files or design dossiers
- Working experience in Banking Operations or Compliance Operations
- Responsible for planning own workload typically against a backdrop of changing priorities
6
Skills For Regulatory Operations Associate Resume
- Experience gained in an operations management role which had responsibility for overseeing multiple facilities and their license agreements
- Proven abilities to anticipate and address stakeholder needs in problem solving and risk mitigation
- Experience with electronic publishing tools and electronic document management systems
- Operations experience working with legal and compliance teams
- Experience in working with Customer Support (preferably Zendesk) and/or any offshore partner teams
- Understand and react to changing priorities even when not all the information is available
7
Skills For Regulatory Operations Supervisor Resume
- Experience with eCTD publishing software preferable
- Proficient experience with submission publishing software and tools e.g. OmniFile, Insight Publisher, ISI toolbox, etc
- Experience in associated regulations relevant to labeling and use of international symbols
- Effective working in multidisciplinary teams
- Demonstrate a high level of regulatory operations expertise in one or more global regions e.g., US, Europe, Japan, Canada, Australia, Emerging Markets, etc
- Demonstrated proficiency using MS Office applications (i.e. Outlook, email, Excel, Word, and PowerPoint)
- Manage routine details and unexpected changes while maintaining focus on projects; determine task priority and ensure deadlines are met
- Strong focus on producing high quality results
- Capability to maintain and manage strong working relationships with other groups both internally and externally
8
Skills For Senior Regulatory Operations Analyst Resume
- RAPS, SOCRA or ACRP Certification and 7+ years of related experience in Regulatory Affairs, Clinical Trials Management or relevant scientific field is prefered
- Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable
- Previous experience in a similar Operations Manager role
- Previous experience with Hazardous Substance licences/permits
- Handle and prioritize detailed tasks
- Experience in review and approval process of pharmaceutical/biologics documentation
- Experience in the pharmaceutical/medical industry
- Contributes to global and/or regional Licence to Operate initiatives to support Syngenta’s future business
9
Skills For Director, Regulatory Operations Resume
- Two years’ experience in SEC and FINRA regulations applicable to Broker-Dealer Operations
- Experience in Regulatory Affairs, Research, Development or related
- Work experience in regulatory healthcare operations compliance required
- Familiarity with system validation practices
- Able to understand, consolidate diverse and complex business information and identify/mitigate operational risk issues
- Experience with authoring Chemistry, Manufacturing and Controls (CMC), Nonclinical, Clinical submissions in CTD format
10
Skills For Director, Global Regulatory Operations Resume
- Experience working with federal or state authorization and licensing agencies
- Experience using submission publishing software
- Experience with regulatory publishing software tools such as eCTDXpress, Liquent Insight publisher, ISITool Box
- Experience compiling electronic submissions
- Experience in electronic document publishing
- Extensive experience using electronic document management systems
List of Typical Responsibilities For a Regulatory Operations Resume
1
Responsibilities For Regulatory Operations Specialist Resume
- Proven ability to prioritize in challenging situations and competing demands
- Experience in identifying, documenting and presenting client technical needs, internal structures, procedures, workflows and systems
- Knowledge/Experience/Qualifications – Sanctions & AML PEP screening; CTR Risk Monitoring; Understanding LoB Product risks
- Manage projects and create project plans and timelines · juggle multiple and competing priorities
- Assist with data entry and analysis as needed, ensuring data quality and validity
- Excellent reading comprehension in English
- A solid and robust control orientated background
2
Responsibilities For Regulatory Operations Manager Resume
- Experience and knowledge of business analysis methods and tools
- Experience in Regulatory Affairs/Regulatory Operations in the pharmaceutical/biotechnology industry
- Demonstrated ability to successfully interact with regulatory authorities on the technical aspects of electronic regulatory submissions
- Provides guidance on good documentation and submission practices
- Working with other teams within Portfolio Services to establish the reason behind any such validation errors or rejections
- Demonstrated ability to evaluate and select submission and archival software
- Mapping the process plans for each of the proposed recommendations and working with the Lead Product Business Analyst’s to implement solutions
- Formatting and Publishing
- Working knowledge of databases systems and reporting (SAP, Business Objects, MS Access)
3
Responsibilities For Manager, Regulatory Operations Resume
- Working knowledge of document management systems (e.g. PLM, Agile, Documentum, RAD, ENovia,
- Training and appropriate knowledge of FDA and other international document submission requirements and regulations
- Working knowledge of SAP, Agile, or related system
- Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development
- Depending on specific area of responsibilities typically 10% to 40%
- Ensuring all work is auditable by maintaining complete records in the database
- Manage the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with the client
4
Responsibilities For Regulatory Operations Operator Resume
- Increase departmental efficiency and scalability by analyzing team workflows and crafting and testing solutions
- Assist the VP of Regulatory with identifying and completing department objectives, expense tracking and budget preparations
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
- Responsible for hiring, managing and coaching direct reports to build capacity for anticipated original BLA and MAA submissions
- Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form
- Advanced knowledge of word processing, spreadsheet/graphing, Microsoft Office applications, including Word, Excel, PowerPoint
5
Responsibilities For Senior Regulatory Operations Specialist Resume
- Maintain a cohesive team by training, and mentoring direct reports
- Capable of multi-tasking while staying organized and detailed oriented
- Provide publishing guidance and input and timing on project submission team timelines
- Perform complex compilation and publishing activities of new and existing regulatory applications
- Assist with managing eCTD templates and accompanying template style guide
- Perform document-level publishing and formatting documents for submission readiness
- Provide input regarding assigned projects in support of submission scheduling and coordination of system development activities
6
Responsibilities For Regulatory Operations Associate Resume
- Assist with developing detailed project timeline information to support resource forecasting
- Identify and recommend product solutions to automate recurring operational processes, proposing data-driven solutions to all stakeholders
- Maintain and provide regulatory information in support of MITG wide initiatives for general scoping and planning for the BU RA teams
- Monitor and support consistent execution of MITG training process and training programs
- Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly
- Knowledgeable of Medical Device Reporting (MDR) process and interested in becoming Regulatory Affairs Certified (RAC) to better assist department needs
- Knowledge of relevant mainframe systems and Operational aspects of FCC Compliance monitoring/screening systems
- Take a project from start to finish while working in a constantly changing environment
7
Responsibilities For Regulatory Operations Supervisor Resume
- Highly data driven: Comfortable with handling large datasets and deriving actions from them. Fluent with Excel
- Have an understanding of upcoming industry initiatives such as CAT NMS Plan
- Responsible for formatting word documents by applying appropriate style or templates to assure the standards outlined in the applicable guidance are met
- Provide status reporting on a frequent basis regarding completion of major projects in master calendar
- In carrying out your supervisory responsibilities, review for indications of non-compliance with Firm Polices, notify the appropriate risk and control areas of
8
Responsibilities For Senior Regulatory Operations Analyst Resume
- Investigate, resolve exceptions & track metrics related to the following
- Map resources and map future resource needs by having a long term vision for the group
- Oversee ClinicalTrials.Gov trial registration, updates and ongoing maintenance of trial status, as applicable
- Familiarity with technologies (e.g., eCTD systems, ESG, XML) to support electronic submissions and labeling preferable
- ECTD submission publishing for FDA (IND and NDA)
- Support clinical studies by reviewing documentation for regulatory compliance
9
Responsibilities For Director, Regulatory Operations Resume
- Acts as regulatory operations liaison to gather documents, communicate deadlines, and to help with document formatting for document authors
- Design and provide formal internal training on templates and other submission-related documentation and systems
- Develops, implements and oversees maintenance of technologies and infrastructure needed to support regulatory and medical writing operations
- Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities
- Act as liaison with Covidien International regulatory personnel to address questions and issues that arise as part of the registration and/or testing process
- Obtain and maintain CFGs including the notarization and legalization, EC/ISO Cert’s and various other regulatory documents
- Maintain and update TRAIN database (used for tracking of international registration requests) as administrator
10
Responsibilities For Director, Global Regulatory Operations Resume
- Write and maintain procedures ensuring they are updated as required
- Build and automate actionable reporting for key RegOps processes
- Work with engineering teams to understand the intricacies of legacy data
- Maintain credentials for GMDN codes and FDA e-filing services (pertinent to market authorizations and Medical Device Reports)
- Process market authorization submissions (compilation, e-copy, filing)
- Perform regulatory assessment of distributed product qualifications (including acquisitions) and related changes
- Carry out other tasks as assigned, including tasks related to the regulatory needs of VSZL
- Coordinate and communicate with other lines of business within support, to keep them updated and engaged on what’s going on in the world of compliance
- Develop and improve internal processes to respond more quickly to fast-changing regulatory issues that impact support
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