Director, Regulatory Affairs CMC
About The Position
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com. Lead the preparation of CMC Regulatory documents from pre-IND to marketing authorization submissions in multiple therapeutic areas, molecules, and regions. This position will lead direct reports in the CMC regulatory team, keep up to date on evolving regulations, and lead regulatory intelligence activities. This is a hybrid role that typically requires on-site presence three days per week.
Requirements
- Bachelor's or advanced degree in a scientific discipline, with 10+ years of experience working in Regulatory Affairs in the biopharmaceutical industry
- Experienced in building, developing, and managing high functioning teams
- Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/MAA
Nice To Haves
- Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
- Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with Global regulatory agencies
- Excellent verbal and written communication skills
- 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
Responsibilities
- Effectively maintain, and motivate a high-performing regulatory CMC team, including developing, coaching, and mentoring diverse, talented, and driven staff
- Lead regulatory - CMC intelligence activities
- Lead regulatory CMC activities for assigned projects consistent with global regulatory requirements , and company policies and procedures
- Provide Regulatory CMC guidance to internal teams and lead cross-functional teams to plan and prepare briefing packages, and 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
251-500 employees
