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Apogee Therapeutics · 1 day ago

Director, CMC and Device Regulatory Affairs

United States

Full-time

Onsite

Director/Executive

$220K/yr - $240K/yr

10+ years exp

Apogee Therapeutics is a biotechnology company focused on developing differentiated biologics for treating inflammatory and immunology indications. The Director, CMC and Device Regulatory Affairs will lead the development and implementation of global regulatory CMC strategies for drug-device combination products, ensuring compliance with regulatory requirements and contributing to broader regulatory objectives.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

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

Qualification

CMC regulatory experienceBiologics knowledgeDrug-device combination productsGlobal regulatory requirementsProject management skillsLeadership skillsCommunication skillsDetail-oriented

Required

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

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

Preferred

Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions

Benefits

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

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)