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Senior Manager, Regulatory Affairs CMC
Cambridge, MA
Job Description
The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. The Senior Manager will also contribute to the development of fit for purpose high quality documentation (e.g. INDs, CTAs, BLAs, reports, and correspondences) to support global Health Authority interactions. They will build/maintain relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. They will also apply and further develop knowledge of assigned market regulatory procedures.
Primary Responsibilities Include:
- Contributes to developing CMC regulatory strategies for assigned projects and programs while accurately interpreting and reflecting regulatory and corporate guidelines
- Coordinates the preparation, writes and reviews submission-ready CMC and marketing registration applications, supplements, amendments, and variations
- Responsible for completing change control regulatory assessments, maintenance of regulatory tracker and submission preparation activities
- May lead CMC submissions and agency responses
- Ensures documentation management and record-keeping are compliant with regulatory expectations and Sarepta SOPs
- Required to support preparation for inspection readiness
- Maintains and further develops knowledge of relevant evolving regulation and guidance
- Global Regulatory Teams contributor to establish and implement regulatory strategy
Desired Education and Skills:
- Must thrive working in a fast-paced, innovative environment demonstrating flexibility and a proactive approach.
- Excellent interpersonal, collaboration, written, verbal and visual communication skills with ability to influence cross-functionally at all levels within the organization.
- Knowledge of drug development, ICH guidelines and regulatory process and working with cross-functional teams.
- Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders.
- BS or equivalent with 8+ years relevant experience
- Experience with preparing INDs, IMPDs, BLA, NDA and/or MAA submission(s) is essential
- Experience of IND/ CTA, IMPDs, Orphan drug designation, Agency Advice, NDA and/or MAA submission
- Demonstrated experience with and a clear understanding of submission content and format requirements
- RAC certification recommended
- Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems
This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
8+ years
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