Global Regulatory Operations Lead - Submissions & eCTD

Regulatory Jobs; Princeton (NJ); Ibrido; USD 146.000 - 183.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision insurance

401(k) plan with company match

Employee Stock Purchase Plan

Vacation and paid holidays

Descrizione del lavoro

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global regulatory submissions, RIM, and document management. This role drives submission planning, maintains inspection-ready records, and partners with cross-functional teams and external providers to ensure compliant, efficient processes.

A strong background in eCTD, EDMS, and global regulations is required. The position supports hybrid work arrangements across US sites, including Princeton, NJ, with

Competenze

• Bachelor's degree in a scientific discipline or related field; equivalent combination considered.
• 8+ years in regulatory operations in pharma/biotech.
• Strong expertise in the eCTD process and publishing software.
• Experience overseeing electronic document management systems (EDMS).
• Thorough knowledge of US/international regulations for Regulatory Operations.

Mansioni

• Lead planning, preparation, formatting, publishing, and archiving of global regulatory submissions.
• Coordinate submission deliverables for INDs, CTAs, NDAs, MAAs, and related documents.
• Provide guidance translating regulatory strategy into operational plans and mitigate risks.
• Ensure compliance with health authority standards and internal procedures.
• Escalate and resolve submission, publishing, document, process, and technology issues.

Conoscenze

Bachelor's degree

Regulatory operations

eCTD process

EDMS oversight

Regulatory knowledge US/Intl

Cross-functional collaboration

Travel ability

Analytical skills

Communication skills

Formazione

Bachelor's degree or equivalent

Strumenti

EDMS systems

Publishing software

RIM tools

Descrizione del lavoro

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global regulatory submissions, RIM, and document management. This role drives submission planning, maintains inspection-ready records, and partners with cross-functional teams and external providers to ensure compliant, efficient processes.

A strong background in eCTD, EDMS, and global regulations is required. The position supports hybrid work arrangements across US sites, including Princeton, NJ, with