Regulatory Affairs Manager
ID: 1697
Date of Posting: Jul 7, 2025
Business Area: Regulatory Affairs
Job Type: Direct Employee
On site / Remote / Hybrid: On Site
Location:Bridgewater, NJ, US

EDUCATION AND EXPERIENCE

• Bachelor’s degree required; advanced degree in the life sciences preferred.
• A minimum of 5 years’ experience in Regulatory Affairs
• Experience in a commercial-stage organization required.
• Demonstrated ability to deliver quality results within a fast-paced, dynamic environment.

KNOWLEDGE AND SKILLS

• Knowledge of current FDA and Health Canada regulations and guidance; and knowledge of and experience with pharmacovigilance and related drug safety reporting regulations.
• Ability to manage multiple priorities and regulatory submissions at different stages as required.
• Strong project management skills with proven ability to drive projects through to completion.
• Working knowledge of Veeva platform helpful but not required.

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

• Implement regulatory strategies supporting drug development and lifecycle management for US and Canada.
• Review documentation and prepare lifecycle management submissions.
• Review documentation and prepare drug development activity of pre-IND and IND submissions.
• Liaise with regulatory authorities as needed pertaining to drug development and product lifecycle management.
• Oversee submission of advertising and promotional material to the FDA as required.
• Support the labeling and/or change control processes to ensure timely and comprehensive review.
• Maintain labels/labeling for newly acquired and existing products in compliance with regulatory requirements and company standards.
• Track Annual Report and Periodic Safety Update Reports (PSUR) schedules to ensure that required dossiers are prepared and submitted as required.
• Coordinate with Medical Affairs & Pharmacovigilance to ensure timely reporting of safety data to regulatory agencies and partners.
• Ensure compliance with all federal regulations regarding post-marketing reporting to the FDA and other health authorities.
• Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
• Perform additional duties as may be assigned.