US Regulatory Affairs Manager

1 week ago


Saugus, Massachusetts, United States Lundbeck Full time
About Lundbeck

Lundbeck is a global biopharmaceutical company dedicated to advancing brain health and improving the lives of people with neurological and psychiatric diseases.

Job Description:Senior Manager, Regulatory Strategy (US RA)

The Senior Manager, Regulatory Strategy (US RA) plays a crucial role in ensuring the successful US development and approval of assigned drug and biological products. This includes participating on global cross-functional teams, maintaining compliance with regulatory requirements, and providing expert advice on US regulatory matters.

Main Responsibilities:
  • Provides regulatory review of product documentation for accuracy and compliance with FDA regulations.
  • Manages US regulatory perspective at Regulatory Affairs Focus Team meetings and represents the company's interests.
  • Identifies risk, problem-solves, and offers solutions to ensure successful regulatory submissions.
  • Serves as US subject matter expert to support strategy development and execution for assigned products.
Requirements:
  • Accredited Bachelor's Degree in a relevant field.
  • 7+ years of experience in the pharmaceutical and/or biotech industry or a consulting company supporting the pharmaceutical and/or biotech industry.
  • 5+ years of direct experience in US Regulatory Affairs.
Why Join Lundbeck?

Lundbeck offers a comprehensive benefits package, including flexible paid time off, health benefits, and a 401(k) plan. We are committed to equal employment opportunity and participate in E-Verify.



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