Manager, Regulatory Affairs

Position Overview:

The Manager, Regulatory Affairs provides regulatory support for marketed products and development programs, working cross-functionally to file and maintain applications in compliance with applicable regulations.

Responsibilities:

• Prepare Investigational New Drug (IND) and New Drug Application (NDA) submissions to the FDA.
• Ensure submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and other applicable requirements.
• Collaborate with Commercial, Medical, Technical Operations, and other partners to plan, compile, and submit required information to FDA and other Health Authorities.
• Manage and coordinate materials necessary for regulatory filings.
• Serve as primary interface with regulatory publisher for electronic submissions via FDA’s submission gateway.
• Prepare IND Annual Reports, NDA Annual Reports, and Periodic Adverse Drug Experience Reports.
• Oversee maintenance of regulatory files and document systems.
• Manage labeling for approved and investigational products (U.S. prescribing information, clinical trial labeling, packaging components) and coordinate cross-functional reviews for regulatory compliance, accuracy, and consistency.
• Uphold Core Values; be accountable for team goals; communicate clearly; implement continuous improvements; solve routine problems; develop skills in a narrow technical domain; coach others (may have direct reports).

Qualifications:

• Bachelor’s degree required; Master’s strongly preferred.
• 4–6 years of related experience in Pharmaceutical or Life Sciences required.
• Strong knowledge of applicable regulations.
• Experience with document management systems and electronic publishing required.
• Strong verbal and written communications skills.
• Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.

Pay Range:

$132,219 USD - $158,400 USD