# Director, Regulatory Affairs CMC at Acadia Pharmaceuticals

- Company: Acadia Pharmaceuticals
- What the company does: Acadia advances care for underserved neurological disorders and rare diseases. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. Backed by NEA.
- Company website: https://acadia.com/
- Type: Startups
- Level: Principal and up
- Location: Princeton, New Jersey, United States; San Diego, California, United States; South San Francisco, California, United...
- Work setup: On-site
- Posted: 2026-08-25
- Apply by: 2026-10-12
- Apply: https://acadia.com/en-us/careers/job-board/8734532002?gh_jid=8734532002
- Page: https://www.1752.vc/careers/jobs/acadia-pharmaceuticals-director-regulatory-affairs-cmc/

## About the role

Please note that this position can be based in San Diego, CA, San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average .

## What they're looking for

- Manages the CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements
- Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy
- Manages the timely preparation of high quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission to regulatory authorities supporting the conduct of clinical trials and marketing applications worldwide
- Contributes as a key regulatory representative with external parties and acts as a point of contact with regulatory agencies for CMC development, product registration, and life-cycle activities
- Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks
- Participates in ensuring compliance of CMC activities with applicable regulatory requirements

Tags: Regulatory Affairs