corcepttherapeutics

Director, Regulatory Affairs CMC

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At a Glance

Location
United States
Experience
10+ years
Compensation
eadquarters-based position is $238,900 – $281,100; the pay ultimately offered m
Posted
2026-02-13T18:43:21-05:00

Key Requirements

Domain Knowledge

  • Advertising
  • Education
  • Medical
  • Pharmaceutical
  • Regulatory

Requirements

Nice to have:

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

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