RA CMC Senior Director​/Executive Director-small molecule

The Regulatory Affairs CMC will lead global CMC regulatory strategies for development and commercial products. This role is responsible for the preparation, review, and submission of high-quality CMC dossiers (INDs, IMPDs, NDAs, MAAs, BLAs, post-approval variations) and for ensuring compliance with global regulatory requirements. The Director will serve as the CMC regulatory lead on cross-functional project teams and will manage and mentor CMC regulatory staff.

• Develop and execute global CMC regulatory strategies aligned with product development, registration, and lifecycle management goals.
• Lead preparation, review, and timely submission of CMC sections for INDs/CTAs, NDAs/BLAs/MAAs, amendments, annual reports, and post-approval changes.
• Assess proposed manufacturing changes (site, process, specifications, etc.) for regulatory impact and define global filing strategies.
• Provide regulatory guidance on comparability protocols, stability programs, analytical methods, and process validation.
• Monitor and interpret evolving CMC regulatory requirements from FDA, EMA, PMDA, NMPA, and other health authorities.
• Ensure submissions meet quality, consistency, and data integrity standards.
• Lead responses to health authority queries related to CMC during review cycles and inspections.

• Partner with Quality, Manufacturing, Supply Chain, Analytical Development, and Process Development teams to align CMC data with regulatory expectations.
• Represent CMC regulatory affairs in project team meetings, due diligence, and risk assessments.
• Manage and mentor junior CMC regulatory staff, fostering technical and regulatory expertise.
• Liaise with contract manufacturing organizations (CMOs) and testing labs to collect and review CMC source documentation.
• Support health authority inspections (pre-approval, GMP, etc.) from a CMC regulatory perspective.

• Bachelor’s degree in life sciences, chemistry, pharmacy, chemical engineering, or related field. Advanced degree (MS, PhD, PharmD) strongly preferred.
• Minimum 10+ years of regulatory CMC experience in the pharmaceutical, biotech, or biologics industry, with at least 3–5 years in a leadership/managerial role.

• Deep understanding of small molecules development (Biologics, gene therapy, cell therapy, or antibody–drug conjugate experience is a plus).
• Hands‑on experience with ICH guidelines, CTD/eCTD structure, and global submission requirements (US, EU, RoW).
• Proven track record of successful INDs/CTAs, NDAs/MAAs/BLAs, and post‑approval lifecycle management filing.
• Strong analytical and problem‑solving skills to evaluate manufacturing changes and assess regulatory risks.
• Excellent written and verbal communication skills; ability to author and critique technical documents.
• Experience interacting with health authorities (FDA Type A/B/C meetings, EMA scientific advice, etc.)
• Ability to work effectively in matrixed, fast‑paced environments with cross‑functional teams.
• Demonstrated ability to mentor and develop junior regulatory staff.
• Detail‑oriented, organized, and capable of managing multiple high‑priority submissions simultaneously.