Executive Director

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. Key Responsibilities Regulatory Strategy & Submissions 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. Cross-Functional Leadership 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. Qualifications Education & Experience 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. Technical Knowledge 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. #J-18808-Ljbffr