Director, Regulatory Affairs CMC

Director, Regulatory Affairs CMC Redwood City, California, United States Lead the preparation of CMC regulatory documents from pre‑IND to marketing authorization submissions across multiple therapeutic areas, molecules, and regions. This hybrid role will be on‑site three days per week and will manage a team of regulatory professionals, staying current on evolving regulations and leading regulatory intelligence activities. Responsibilities Effectively maintain, motivate, develop, coach, and mentor a high‑performing regulatory CMC team Lead regulatory‑CMC intelligence activities and regulatory‑CMC activities for assigned projects, ensuring compliance with global regulations, company policies, and procedures Provide regulatory CMC guidance to internal teams and lead cross‑functional teams in preparing briefing packages, CMC sections for INDs, and equivalent IMPD sections for CTAs, NDAs/MAAs, and other global submissions Assess the regulatory impact of proposed manufacturing process changes Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports Lead interactions with regulatory agencies for assigned programs Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines, and communicate changes in regulatory information to cross‑functional teams Preferred Skills, Qualifications and Technical Proficiencies Successfully led responses to health authorities or other critical submissions while maintaining agreed timelines Demonstrated leadership and success in managing regulatory activities with a proven track record of effective collaboration with global regulatory agencies Excellent verbal and written communication skills Preferred Education and Experience Bachelor’s or advanced degree in a scientific discipline; 10+ years of experience in Regulatory Affairs in the biopharmaceutical industry Experience building, developing, and managing high‑functioning teams Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filings such as IND/CTA or NDA/MAA Direct experience with regulatory submissions to PMDA is desirable Experience with small molecules is preferred Experience in successfully leading assigned activities within cross‑functional teams The pay range that the company reasonably expects to pay for this headquarters‑based position is $238,900 – $281,100; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job‑related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full‑time basis. Corcept is an Equal Opportunity Employer #J-18808-Ljbffr