Global Regulatory Operations Lead — Submissions & Data

Acadia Pharmaceuticals; South San Francisco (CA); On-site; USD 146,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) Plan with company match

Employee Stock Purchase Plan

15+ vacation days

Paid holidays

Job summary

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global submission planning, publishing, and information management. The role partners with Regulatory Affairs and cross-functional teams to ensure inspection-ready processes and systems, with a focus on eCTD and EDMS governance.

The position requires strong regulatory know-how, independence, and the ability to drive continuous improvement through automation and data quality.

Qualifications

• Bachelor’s degree in scientific discipline; 8 years regulatory operations experience.
• Strong eCTD expertise and EDMS oversight.
• Experience with publishing software and regulatory submissions.
• Ability to influence cross-functional teams and vendors.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead planning, formatting, publishing, QC and archiving of global regulatory submissions.
• Coordinate submission deliverables for INDs, CTAs, NDAs, and other filings.
• Provide tactical guidance to global regulatory teams and external partners.
• Ensure compliant, inspection-ready records and systems.
• Drive continuous improvement with governance and data quality.

Skills

Regulatory Operations Leadership

eCTD expertise

EDMS oversight

Publishing software proficiency

Cross-functional collaboration

Problem-solving

Travel willingness

Education

Bachelor’s degree in scientific discipline

Tools

EDMS systems

Publishing software

Job description

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global submission planning, publishing, and information management. The role partners with Regulatory Affairs and cross-functional teams to ensure inspection-ready processes and systems, with a focus on eCTD and EDMS governance.

The position requires strong regulatory know-how, independence, and the ability to drive continuous improvement through automation and data quality.