Senior Associate Director, Regulatory Operations

Acadia Pharmaceuticals; Princeton (NJ); Hybrid; USD 146,000 - 183,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Travel insurance

401(k) with company match

Employee Stock Purchase Plan

Vacation days

Paid holidays

Paid sick time

Parental leave

Tuition assistance

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.

The position requires extensive experience with eCTD, EDMS, and regulatory publishing tools, along with strong leadership and strategic execution capabilities.

Qualifications

• Bachelor’s degree in scientific discipline or related field.
• 8 years of regulatory operations experience in pharma/biotech.
• Strong expertise in the eCTD process and electronic document management.
• Ability to influence cross-functional teams and stakeholders.

Responsibilities

• Lead planning, preparation, 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 operational plans.
• Maintain complete, traceable regulatory records to support inspection readiness.
• Drive governance, data quality, automation, and continuous improvement in regulatory systems.

Skills

Regulatory operations

eCTD

EDMS

Regulatory strategy

Cross-functional influence

Travel readiness

Education

Bachelor’s degree in science

Tools

EDMS

Regulatory publishing tools

eCTD 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.

The position requires extensive experience with eCTD, EDMS, and regulatory publishing tools, along with strong leadership and strategic execution capabilities.