Senior Manager Regulatory Strategy

4 days ago


Deerfield Beach, Florida, United States Lundbeck Full time
Senior Manager Regulatory Strategy

Lundbeck is a global biopharmaceutical company dedicated to improving the lives of people with neurological and psychiatric diseases. We are seeking a highly skilled Senior Manager Regulatory Strategy to support the creation and implementation of regulatory strategies for our US development and approval of assigned drug and biological products.

Key Responsibilities:

  • Provides regulatory review of product documentation for accuracy and compliance with FDA regulations.
  • Manages and reviews US regulatory perspective at Regulatory Affairs Focus Team meetings.
  • Identifies risk, problem-solves, and offers solutions for regulatory submissions.
  • Liaises with regulatory authorities for all drug development and approval aspects.
  • Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives.

Requirements:

  • Accredited Bachelor's Degree.
  • 7+ years within the pharmaceutical and/or biotech industry or for a consulting company supporting the pharmaceutical and/or biotech industry.
  • 5+ years direct experience in US Regulatory Affairs.
  • Direct experience in US drug development and regulatory submissions.

About Lundbeck:

Lundbeck is committed to easing the burden of the millions of people living with brain disorders. We develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.



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