Director, Regulatory CMC

Responsibilities

• Serve as the regulatory CMC representative on cross-functional teams for assigned programs and execute deliverables in alignment with strategies established by Global Regulatory Affairs and Technical Operations.
• Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with internal and external stakeholders.
• Cook up and support the timely execution of regulatory filings and submission activities in compliance with applicable global regulatory requirements, commitments, and internal timelines.
• Prepare regulatory CMC meeting requests, briefing materials, and supporting documentation to enable effective health authority interactions and internal governance reviews.
• Assess CMC change controls to determine regulatory impact, identify filing requirements across regions, evaluate supporting documentation, and escalate risks or gaps as appropriate.
• Track regulatory commitments, health authority questions, and submission-related action items, and coordinate cross-functional responses within agreed timelines.
• Maintain current knowledge of relevant CMC regulations, guidance, and regional expectations, and communicate executional impact to internal stakeholders.
• Contribute to continuous improvement of regulatory processes, templates, SOPs, and systems that support efficient and compliant document development and submission execution.

Qualifications And Skills

• A minimum of a B.S. degree in a scientific or life sciences discipline with a minimum of 10 years experience in Regulatory CMC, manufacturing, analytical development, quality, or related pharmaceutical development environments.
• Demonstrated experience supporting regulatory programs for products intended to treat rare diseases and/or conditions with high unmet medical need is preferred.
• Experience preparing CMC documentation to support clinical trial applications, marketing applications, post-approval submissions, and health authority responses.
• Experience with peptides and injectable dosage forms and/or injection drug delivery devices is required.
• Strong execution skills with demonstrated ability to manage multiple deliverables, coordinate cross-functional input, and deliver high-quality work within aggressive timelines.
• Working knowledge of global CMC regulatory requirements, guidelines, and expectations across development, registration, and lifecycle management in multiple ICH regions.
• Ability to work independently within established strategic direction, identify issues proactively, and escalate risks appropriately.
• Strong organizational, planning, communication, and collaboration skills, with the ability to work effectively across Global Regulatory Affairs, Technical Operations, Quality, and external partners.

Pay

The expected salary range for this position is $182,000 - $275,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance.