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Director, CMC and Device Regulatory Affairs

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Apogee Therapeutics

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Location:

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

220000.00 - 240000.00 USD / Year
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Job Description:

The Director, CMC and Device Regulatory Affairs will lead the implementation of global regulatory CMC strategies for drug-device combination products (e.g., prefilled syringes and autoinjectors) across all phases of development through licensure, ensuring compliance with global regulatory requirements. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products. This functions as a strategic partner, contributing to strategy development, leading key initiatives, and supporting broader regulatory objectives.

Job Responsibility:

  • Develop and implement global CMC and device regulatory strategies for assigned program(s)
  • Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
  • Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
  • Identify regulatory risks associated with product development and propose mitigation strategies
  • Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
  • Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
  • Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
  • Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth

Requirements:

  • Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
  • Minimum of 10 years of industry experience
  • At least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
  • Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred
  • Proven track record of leading cross-functional submission teams and successful regulatory submissions
  • Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
  • Excellent communication, leadership, and project management skills
  • Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
  • Up to 15 – 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
What we offer:
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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