Director, Regulatory Affairs CMC
Corcept Therapeutics - Redwood City, California, United States
Posted Feb 5, 2026
Benefits
- Parental leave
- Not verified
- Non-birth-parent leave
- Not verified
- Family-building benefits
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- Fertility benefits: Not verified
- Adoption assistance: Not verified
- Surrogacy assistance: Not verified
- Mental health support
- Not verified
- Relocation assistance
- Not verified
- Childcare support
- Not verified
- Learning budget
- Not verified
- Verification
- Not verified checked Jun 7, 2026
- Salary
- $239K-$281K From the posting source
- 401(k) match
- Reported from DOL Form 5500 industry filing (not employer-specific)
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Role
- Seniority
- Staff Plus From the posting source
Schedule
- Shift type
- Not verified
- Weekend work
- Not verified
Company
- Equity
- Offered Verified - SEC 10-K source
Application
- Cover letter
- Not verified
- Assessment
- Not verified
- Deadline
- Not stated
Where they hire
State eligibility is not yet verified.
About this role
Director, Regulatory Affairs CMC Redwood City, California, United States 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. 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
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