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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Plan, prepare, publish, quality-check, dispatch, and track electronic regulatory submissions in accordance with global regulatory requirements, internal standards, and committed timelines
- Coordinate submission activities with Regulatory Affairs leads, authors, reviewers, vendors, and other stakeholders, proactively identify risks, dependencies, and timeline impacts
- Ensure submission-ready documents meet applicable formatting, technical, metadata, and lifecycle requirements, including eCTD and other regional electronic submission standards
- Monitor RIM data for completeness, accuracy, consistency, and timeliness from regulatory planning through submission and health authority interaction, coordinate remediation with data owners
- Ensure required metadata are entered and maintained for regulatory objects, documents, activities, submissions, applications, registrations, and correspondence to support downstream processes, reporting, and traceability
- Partner with stakeholders to define, document, and improve regulatory processes, work instructions, job aids, controlled procedures, and data standards
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
The Manager, Regulatory Operations supports the planning, preparation, publishing, submission, tracking, and lifecycle management of global regulatory submissions. The role partners with Regulatory Affairs, cross-functional contributors, Information Technology, Quality, and external vendors to ensure submission content...
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