Regulatory Affairs Manager - Framingham, MA or Remote (East Coast / Northeast)
The Regulatory Affairs Manager will assist in developing regulatory strategy and participate on various product development teams. The Manager will assist in the preparation, writing and submission of regulatory documents such as pre-IND meeting requests, INDs, BLAs, amendments, and other regulatory submissions as required in collaboration with appropriate leadership. This individual will provide regulatory advice and guidance to cross-functional product development teams.
This position requires knowledge of U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH guidelines, and a familiarity with GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211).
It also requires:
- Review of information to be presented in regulatory submissions to ensure that it is clear, comprehensive, accurate and factually correct.
- Coordination with domestic and international Clinical Research, Clinical Operations, Manufacturing, QA/QC, Marketing, Legal and other groups to assure timely and accurate preparation of regulatory documentation.
- Preparation, publishing, and submission of INDs, BLAs, amendments, annual reports, and supplements for submissions to FDA and other health authorities.
- Work closely with Regulatory Director on product development teams, providing advice on CMC submission planning.
- Track the committed timeliness and follow up with the internal departments proactively for required documents.
- Provide accurate and timely assessment of change control documents for determination of reporting category.
- In collaboration with the Regulatory Director, provide appropriate regulatory guidance to quality and manufacturing/operations.
- Coordination with team members, CROs, contract vendors and others in the preparation, publishing and submission of INDs, IND amendments, etc.
- Prepare and review standard operating procedures and policies.
- Maintain a working knowledge in the specific areas related to GCP, GLP and GMP compliance including, but not limited to regulatory and ICH requirements.
- Maintain a working knowledge of U.S. and international drug and biologic research regulations.
- Assist senior staff during regulatory inspections.
- Assist with communicating the interpretation of current and new laws, rules/regulations, and guidance.
- BA/BS in a scientific discipline and a minimum of 3 to 5 years regulatory affairs experience in the biopharmaceutical area, or equivalent is required. A broad understanding of the drug development process is required together with knowledge of the post-marketing requirements. Furthermore, a working knowledge of Regulatory expectations for development and registration of complex glycoproteins (recombinant and [desirable] human plasma-derived). Must have solid working knowledge of multiple computer software programs and exceptional computer skills.
- The ability to set up and maintain regulatory files and submission archives, both electronic and paper, to assure proper storage and retrieval of regulatory documentation.
- Excellent communication skills, both verbal and written, including appropriate use of medical, scientific, and Regulatory terminology.
- Excellent interpersonal skills.
- The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events.
- Understand the drug and biologic development process.
- Understand clinical research process including medical and clinical terminology.
- Understand non-clinical research process including terminology.
- Understand manufacturing processes including terminology.
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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