Global Regulatory Operations Lead — Hybrid (Equity Eligible)

ACADIA Pharmaceuticals Inc.; Princeton (NJ); Híbrido; USD 146 000 - 183 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Insurance

401(k) Plan

Employee Stock Purchase Plan

Equity packages

Vacation days

Holidays

Sick time

Parental leave

Tuition assistance

Resumo da oferta

Acadia Pharmaceuticals Inc. is seeking an Associate Director of Regulatory Operations to lead global submission planning, information management, and document control for development and marketed products.

You will partner with Regulatory Affairs and cross‑functional teams, including external vendors, to ensure inspection‑ready processes and systems. The role requires strong experience with the eCTD process, EDMS oversight, and regulatory publishing tools; you will drive continuous improvement

Qualificações

• Bachelor’s degree in scientific discipline or related field; equivalent experience may be considered.
• 8+ years in regulatory operations within pharma/biotech.
• Strong expertise in eCTD, EDMS oversight, and publishing tools.
• Thorough knowledge of US and international regulations applicable to Regulatory Affairs Operations.
• Ability to influence cross‑functional partners and drive improvements.

Responsabilidades

• Lead global regulatory submissions planning, formatting, publishing, QC, dispatch and archiving.
• Coordinate deliverables for INDs, CTAs, NDAs, MAAs, amendments, safety letters, and briefing documents.
• Provide tactical guidance translating strategy into executable operational plans; mitigate submission risks.
• Govern regulatory information management and document management capabilities; ensure compliance and inspection readiness.
• Partner with IT, QA, and vendors on system implementations, validation, and support.
• Develop SOPs, templates, and training materials; drive process improvements.

Conhecimentos

eCTD expertise

Regulatory operations leadership

Cross-functional collaboration

Analytical thinking

Formação académica

Bachelor’s degree in scientific discipline

Equivalent education/experience

Ferramentas

EDMS oversight

Regulatory publishing tools

eCTD software

Descrição da oferta de emprego

Acadia Pharmaceuticals Inc. is seeking an Associate Director of Regulatory Operations to lead global submission planning, information management, and document control for development and marketed products.

You will partner with Regulatory Affairs and cross‑functional teams, including external vendors, to ensure inspection‑ready processes and systems. The role requires strong experience with the eCTD process, EDMS oversight, and regulatory publishing tools; you will drive continuous improvement