Regulatory Affairs Job Description
Regulatory affairs
provides guidance and support sites with the implementation of Medical Device Quality Management Systems compliant to FDA Quality System Regulations (QSR), and other applicable ISO standards including ISO13485, ISO14971, etc.
Regulatory Affairs Duties & Responsibilities
To write an effective regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensuring consistency, completeness and adherence to standards for all regulatory submissions
Maintain up-to-date knowledge on international and domestic regulatory requirements
Perform Regulatory Affairs activities ensuring compliance with FDA, Health Canada and UK MHRA and other regulatory agencies including but not limited to
Lifecycle management of existing US approved products, including regulatory impact assessments and strategy development for supplemental applications
Liaising with the FDA and HC or other regulatory authorities, to monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay
Monitor and interpret regulations to evaluate the impact on the business
Ensures compliance with local MOH regulatory requirements CMS and J&J Corporate policies
Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
Manages process for case analytics and implements new methodologies to identify patterns and trends concerning important regulatory topics
Oversees the development and expansion of the Regulatory Contacts database
Regulatory Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Affairs
List any licenses or certifications required by the position: RAC, US, FDA, ETL, UL, USDA, CE, RAPS, EU, GMP
Education for Regulatory Affairs
Typically a job would require a certain level of education.
Employers hiring for the regulatory affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Pharmacy, Engineering, Chemistry, Technical, Life Sciences, Biology, Medical, Education, Business
Skills for Regulatory Affairs
Desired skills for regulatory affairs include:
FDA
Regulations
EU
Regulatory requirements
Standards
Medical device regulations
ISO 13485
Excel
Overall business environment
US
Desired experience for regulatory affairs includes:
Must be goal oriented, able to work within a cross-functional team environment, self-motivated and understand the business needs to meet timelines
Previous related work experience in design and/or manufacturing and/or Quality Assurance of medical devices is required
Previous experience with drug delivery products is preferred
Champions continuous improvement in change control process/documentation
Knowledgeable about the product/process and potential impact the change may have on the product design/process verification and/or validation
Expertise of the requirements for change control, design control, design transfer and risk management
Regulatory Affairs Examples
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Regulatory Affairs Job Description
Job Description Example
Our company is hiring for a regulatory affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory affairs
- Advise internal stakeholders (marketing, manufacturing, R&D, ) regarding current/pending guidance, regulations, Agency/industry initiatives, to ensure regulatory strategy is in alignment with company objectives
- Provide technical interface with FDA and international reviewers and respond to questions
- Support the regulatory team managing international and domestic filings/registrations
- Assist in maintaining product list on Certificate of Foreign Government
- Provide regulatory support to the OEM Deployment group
- Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports
- Submit document change orders (DRO/agile) for approvals
- As requested by supervisor, represent RA department in project meetings and provide regulatory guidance
- Update RA responsible quality system procedures as required (SQP/SOP’s)
- Supervisory oversight for regulatory staff
Qualifications for regulatory affairs
- 2+ years of regulatory experience in a global pharmaceutical and/or biotechnology company
- Minimum of 6 years in regulatory affairs biotechnology CMC
- Consideration will also be given to individuals who have worked for a regulatory agency in a biologics CMC review role with a minimum of 6 years of review experience
- Strong ability to translate technical information related to equipment, processes, and regulatory expectations
- The ideal candidate will demonstrate a strong ability to work independently but also have a keen desire to work in a team environment
- Ability to meet deadlines with consistently superior work product
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Regulatory Affairs Job Description
Job Description Example
Our company is growing rapidly and is looking for a regulatory affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory affairs
- Be a key point of contact for Russia & CIS (in CIS via distributors)
- Regulatory due diligence including evaluation and review of documentation for compliance with approved authorisations
- Preparation of monthly metrics and reports to monitor and cross-compare the quality systems
- Work as a team member in developing the regulatory oversight of CMOs
- Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business
- Ensuring the effective implementation of a quality management system in the Regulatory function
- Be flexible within the Regulatory function to meet the needs of the growing business
- Perform general duties as required by the Regulatory Manager
- Active participation and timely delivery results in RA teams to achieve common goals or attend common strategies
- Supervises the work of translation and dossier contractor with the help of Sr
Qualifications for regulatory affairs
- Bachelor’s degree in Life Sciences, Chemistry, Molecular Biology or similar discipline required
- Ability and desire to progress and represent Acorn Regulatory in an exemplary manner
- As Regulatory Affairs Professional you will be working with development and maintenance/ of the CMC documentation for products (Drug Substances and Drug Products)
- You will perform regulatory assessment of change control cases
- You will prepare regulatory strategies and participate in the preparation of the quality documentation to support clinical trial applications (INDs, IMPDs), new marketing authorisations (NDAs, MAAs) and variation applications in global markets
- In close cooperation with other Regulatory Affairs colleagues, you will plan and project-manage CMC related aspects regarding submissions
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Regulatory Affairs Job Description
Job Description Example
Our company is hiring for a regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory affairs
- Review Engineering Change Requests, Document Change Requests, Labeling, Variances, and other Quality System documentation that requires regulatory review and approval to ensure compliance with national and international government regulations
- Assists in development of procedures to ensure compliance with national and international labeling requirements as outlined in ISO 13485 and 21 CFR Part 801
- Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
- Ensure alignment of regulatory strategy to business strategy across all functional areas
- Ensure that the most current requirements are clear and accurate and proper communication across Franchises were provided
- Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
- Act as business liaison to a portfolio, region, or business unit
- Act as primary contact with the regulatory authorities including the planning and leadership of meeting
- Support more senior RA leadership in the preparation of regulatory filings for new products, product and manufacturing changes
- Review regulatory issues with RA management
Qualifications for regulatory affairs
- You will be part of a cross-functional team, which has the responsibility to create and maintain CMC documentation for drug substances and drug products
- You will also take part in the general activities in the department, including improving and implementing integrated regulatory business processes
- A relevant scientific degree
- Furthermore, you are a strong communicator, passionate and enthusiastic in your way of working
- A professional with positive and proactive influencing skills
- A strong and proactive team player who thrives on working in an international environment
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Regulatory Affairs Job Description
Job Description Example
Our company is looking to fill the role of regulatory affairs. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory affairs
- Provide regulatory guidance and support for development and production activities
- Execute assigned regulatory tasks for device, manufacturing, or labeling changes
- Provide timely review and approval of product labeling and marketing claims for regulatory compliance
- Develop proficiency and maintain awareness of changes in global requirements for effective regulatory submissions
- Translate and communicate regulatory issues and technical reports for nontechnical audiences
- Work effectively with cross-functional staff across multiple sites global external partners
- Assist in the development of regulatory best practices, processes and procedures
- Identify, track, analyze, report on, and proactively engage in relevant legislative and regulatory processes in U.S. Eastern Region states and throughout Canada
- Represent EGP-NA and its interests before a broad range of policymakers with the highest levels of professionalism and ethics
- Ensure EGP-NA’s views are incorporated in broader industry and stakeholder policy positions and strategies
Qualifications for regulatory affairs
- Minimum 5 years working in a GMP / GDP environment
- Capable of monitoring the USP for updates to general chapters and being able to summarize changes
- Must have an understanding of the various roles and responsibilities within a pharmaceutical / biotech supply chain
- 3 + years experience within a regulatory affairs/ compliance environment
- Strong attention to deadlines and details
- Ability to exercise good judgment under pressure
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Regulatory Affairs Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory affairs
- Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies
- Administer training to US and Global Regulatory colleagues for use of Regulatory Affairs documentation databases, Sharepoint sites, processes, and procedures
- Provide insightful and timely research and analysis to EGP-NA Departments to assist in project development and optimization of existing assets
- Lead policy analysis and strategy related to Utility 2.0 regulatory and policy concepts
- Lead Dynegy's policy advocacy at the state and federal (and, as applicable, local) levels
- Develop and implement strategy for advancing Dynegy's policy goals
- Track, monitor and analyze federal and state (and, as applicable, local) policy regulatory developments affecting Dynegy's interests
- Conduct direct outreach to regulators, policymakers, nongovernmental organizations and other stakeholders concerning policy matters and clearly communicate Dynegy's position and policy
- Prepare written comments and present testimony (oral and written) in regulatory, legislative and legal proceedings involving policy matters
- Develop and maintain working relationships with key energy policy personnel at state and federal agencies, nongovernmental organizations, professional associations and other stakeholders
Qualifications for regulatory affairs
- Advanced in Microsoft Office such as Word, Excel, PowerPoint, Project, Outlook and Access
- A detail-oriented individual with a “can do” attitude
- Ability to work in a fast-paced , Project Team environment, with multiple tasks/projects
- Some p revious work experience in a medical device Class II/ III environment
- Experience with the UL/ETL certification process
- Medical Device industry experience with emphasis on IVDD’s