Director, CMC and Device Regulatory Affairs
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $220,000 - $240,000 per year
Job Level
Lead
About the role
- 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, with 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
Benefits
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We provide competitive time off, including 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC regulatory strategiesregulatory submissionsINDsCTAsBLAsMAAsregulatory impact assessmentsregulatory information management systemlate-stage developmentbiologics
Soft skills
communicationleadershipproject managementdetail-orientedteam-orientedcollaborationproblem-solvingadaptabilityinterpersonal skillsorganizational skills