Global Regulatory Operations Lead — Submissions & RIM

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match up to 5%

Employee Stock Purchase Plan

15+ vacation days

13–15 paid holidays

Paid sick time

Tuition assistance

Job summary

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global regulatory submissions, information management, and related technology. This role partners with Regulatory Affairs and cross‑functional teams to ensure compliant, inspection‑ready processes across development and marketed products.

The position requires strong expertise in eCTD, electronic document management, and publishing tools, with a track record of improving governance, data quality, and process

Qualifications

• Bachelor’s degree in scientific discipline or related field.
• Targeting 8 years of regulatory operations experience within the pharmaceutical or biotech industry.
• Must have strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools.
• Must have technical expertise in EDMS oversight.
• Thorough knowledge of US and international regulations as they apply to Regulatory Affairs Operations.
• Willingness and ability to travel domestically and internationally as needed.

Responsibilities

• Lead planning, preparation, formatting, assembly, publishing, quality control, dispatch, and archiving of global regulatory submissions and correspondence.
• Coordinate submission deliverables for applications and lifecycle activities, including INDs, CTAs, NDAs, MAAs, amendments, supplements, health authority responses, and briefing documents.
• Provide tactical guidance to global regulatory teams, translate regulatory strategy into executable operational plans, and identify and mitigate submission risks.
• Interpret and apply current electronic submission standards, health authority technical requirements, internal policies, and operating procedures.
• Serve as a point of escalation for submission, publishing, document, process, and technology issues; drive timely resolution with internal teams, IT and vendors.
• Maintain complete, traceable, accurate, and readily retrievable regulatory records to support inspection readiness.
• Lead and support system governance and administrative processes, including access management, user training and experience, issue management, configuration, change control, release management, validation documentation, and ongoing operational support.

Skills

eCTD process

Electronic document management systems

Regulatory publishing software

Regulatory operations leadership

Cross-functional collaboration

Domestic and international travel

Education

Bachelor’s degree in scientific discipline

Tools

EDMS

Regulatory information management systems

Job description

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global regulatory submissions, information management, and related technology. This role partners with Regulatory Affairs and cross‑functional teams to ensure compliant, inspection‑ready processes across development and marketed products.

The position requires strong expertise in eCTD, electronic document management, and publishing tools, with a track record of improving governance, data quality, and process