Global Regulatory Submissions & RIM Lead

Acadia Pharmaceuticals Inc.; San Diego (CA); Hybrid; USD 146,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Employee Stock Purchase Plan

15+ vacation days

Paid holidays

Paid sick time

Tuition assistance

Job summary

Acadia Pharmaceuticals Inc. in San Diego ( hybrid US ) seeks an Associate Director, Regulatory Operations to oversee global regulatory submissions, information management, and related technology.

The role drives compliant, inspection-ready processes and works with cross-functional partners to maintain high standards of data integrity and regulatory readiness. You will lead submission planning, manage EDMS/RIM systems, and collaborate with external vendors and IT to implement improvements.

Qualifications

• Bachelor’s degree in scientific discipline or related field; equivalent education/experience may be considered.
• Targeting 8 years of regulatory operations experience in the pharmaceutical/biotech industry.
• Strong expertise in the eCTD process and electronic document management/publishing tools.
• Technical expertise in EDMS oversight.
• Thorough knowledge of US and international regulations as they apply to Regulatory Affairs Operations.
• Ability to influence and partner cross-functionally.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead planning, formatting, publishing, and archiving of global regulatory submissions.
• Coordinate submission deliverables for INDs, CTAs, NDAs, MAAs, amendments, and health authority responses.
• Provide tactical guidance to global regulatory teams and translate strategy into executable operational plans.
• Interpret and apply current submission standards and health authority requirements; mitigate risks.
• Serve as escalation point for submission, publishing, document, process, and technology issues; drive timely resolution.
• Maintain complete, traceable regulatory records to support inspection readiness.

Skills

Regulatory operations

eCTD process

EDMS oversight

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in scientific discipline

Tools

EDMS software

Publishing software

RIM systems

Job description

Acadia Pharmaceuticals Inc. in San Diego ( hybrid US ) seeks an Associate Director, Regulatory Operations to oversee global regulatory submissions, information management, and related technology.

The role drives compliant, inspection-ready processes and works with cross-functional partners to maintain high standards of data integrity and regulatory readiness. You will lead submission planning, manage EDMS/RIM systems, and collaborate with external vendors and IT to implement improvements.