Associate Director, Regulatory Affairs CMC

Acadia Pharmaceuticals Inc.(1 month ago)

HybridFull TimeDirector$159,700 - $199,600Regulatory Affairs

About this role

The Associate Director, Regulatory CMC contributes to the development and implementation of global CMC regulatory strategies for investigational and marketed small molecule therapeutics. The role coordinates global CMC regulatory activities to support clinical trials, marketing applications, and product lifecycle management. This position represents the regulatory function on cross-functional development teams and serves as a resource for CMC regulatory requirements and processes.

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Required Skills

CMC Regulatory
Regulatory Strategy
CMC Submissions
Agency Interaction
Cross-Functional Collaboration
Manufacturing Evaluation
Compliance Management
Risk Assessment
Documentation
Negotiation

+3 more

Qualifications

Bachelor's Degree in Life Science

About Acadia Pharmaceuticals Inc.

acadia.com

Acadia Pharmaceuticals is a biopharmaceutical company focused on advancing care for underserved neurological disorders and rare diseases. The company works to translate scientific promise into meaningful innovation by progressing novel therapies from research through clinical development and commercialization. Acadia’s portfolio and pipeline prioritize conditions with high unmet medical need, emphasizing patient-centered development and collaboration to accelerate access to new treatments.