Director, CMC Regulatory Affairs

Role Overview 

We are seeking a dynamic CMC Regulatory Affairs leader to join our Regulatory team. The Director, CMC Regulatory Affairs is a newly created position reporting to the Executive Director, CMC Regulatory Affairs. This role provides strategic and operational leadership for global CMC regulatory activities supporting the development, registration, and lifecycle management of biologic and combination products. Key responsibilities include leading global CMC regulatory strategy, preparing and managing regulatory submissions, briefing documents, and health authority meeting packages, supporting health authority interactions, and providing regulatory guidance on manufacturing processes, analytical methods, specifications, stability, comparability, and post-approval changes. The ideal candidate will bring strong scientific and regulatory expertise, sound judgment, and the ability to interpret complex data and collaborate effectively with internal and external cross-functional stakeholders, including CMC, Quality Assurance, Supply Chain, Clinical, and external partners. This is a fully remote role with occasional travel required.

Key Responsibilities 

· Develop and implement global CMC regulatory strategies for biologic and combination products.

· Prepare and manage CMC submissions, briefing documents, and health authority meeting packages, including INDs, CTAs, BLAs, MAAs, and post-approval filings, etc.

· Serve as the CMC Regulatory lead on cross-functional project teams.

· Support health authority interactions and responses to regulatory questions.

· Provide regulatory guidance on manufacturing, analytical, quality, and lifecycle topics.

· Assess regulatory impact of manufacturing and lifecycle changes and develop risk mitigation strategies.

· Collaborate with internal teams and external partners to support development and commercialization.

· Stay abreast of regulatory trends, guidance documents, and changes to global regulatory requirements affecting CMC.

· Support product release, investigations, inspections, and relevant SOP reviews.

Qualifications 

· Bachelor’s degree in a scientific discipline, such as Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.

· Minimum of 10 years of experience in Regulatory Affairs, CMC, or related pharmaceutical or biotechnology functions, with significant biologics experience.

· Proven experience developing and executing global CMC regulatory strategies for biologics across clinical and commercial stages.

· Strong knowledge of global CMC regulatory requirements and experience with INDs, IMPDs, CTAs, BLAs, MAAs, and post-approval submissions.

· Solid understanding of biologics and combination product development and manufacturing, including analytical methods, process validation, comparability, specifications, and stability.

· Experience supporting health authority interactions, including regulatory meetings and responses to agency questions.

· Ability to assess regulatory impacts of product, process, manufacturing, and lifecycle changes and develop appropriate regulatory strategies.

· Strong leadership, project management, communication, and cross-functional collaboration skills.

· Experience with biologics and combination products, including prefilled syringes and autoinjectors, is preferred.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.