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.
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
More about this role
About Acadia Pharmaceuticals
Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.
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 .
Position Summary
Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through commercialization worldwide. In this leadership position, you will develop and execute global regulatory CMC strategies that support clinical development, marketing approvals,...
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