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Manager/Sr. Manager, Regulatory Affairs

Position Summary: 
Under the supervision of the Director, CMC Regulatory Affairs, the Regulatory Affairs Manager implements CMC regulatory strategy for specific projects, defines CMC requirements, identifies and collaborates with partners in Technical Operations to prepare CMC submissions, and flexibly assists with other projects as determined in a dynamic work environment.


Essential Functions:

  • Responsible for regulatory support in the development, maintenance, and life cycle management of CMC information for products in development and post-approval. 
  • Plan and prepare CMC sections of regulatory submissions (US and global) in various phases of product life-cyle through clinical development, marketing approval, and post-approval, with guidance as needed from Director/Senior Director CMC Regulatory Affairs. This includes defining CMC content (data and documentation) in collaboration with technical operations to compile high-quality submissions.
  • Collaborate with regulatory operations to prepare timely, complete, and high-quality submissions.
  • Lead responses to queries from health authorities in response to INDs, CTAs, NDAs or other applications.
  • Assist in health authority meeting preparation; may be tasked with leading health authority meetings depending on level of experience.
  • Influence technical and project teams to ensure alignment on CMC regulatory strategy.
  • Maintain knowledge of and interpret existing and evolving regulations and communications from health authorities in order to provide guidance to technical operations and project teams.
  • Evaluate proposed changes for regulatory impact and submission requirements, and recommend regulatory strategy for the proposed changes.
  • Responsible for review of protocols, reports, data for conformance with the requirements and expectations of health authorities.
  • Assist with tracking and filing of correspondence and submissions to and from regulatory authorities to ensure commitments are met.

Required Experience and Skills:

  • BA/BS in life or physical sciences, PhD preferred.
  • 5+ years of pharmaceutical or biotech industry experience
  • 3+ years of CMC regulatory affairs experience, preferably with Phase 3 or commercialized products
  • Proficiency in regulatory guidelines (FDA, EMA, ICH)
  • Strong written and oral communication
  • Strategic thinking and problem-solving
  • Ability to collaborate with and influence cross-functional teams
  • Ability to handle and work in ambiguous situations
  • Ability to utilize scientific or technical information to ensure documents are consistent, accurate and complete.
  • Curious and self-motivated
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.

Preferred Additional Skills:

  • Global regulatory experience in EU and other regions
  • Understanding of post-marketing regulatory requirements
  • Experience supporting technology transfer of manufacturing processes
  • Experience reporting post-approval changes
  • Experience with biological products an BLAs
  • Current US work authorization required.
  • Ability to travel domestically and internationally.
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