Senior Manager, Regulatory Affairs CMC

The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy

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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, writing and reviews of 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 regulations and guidance
  • Global Regulatory Teams contribute to establish and implementing 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

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