Onsite Manager, Regulatory Affairs

Posted 7 hours ago

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About the role

  • Manager of Regulatory Affairs driving regulatory strategies for product launches and compliance. Collaborating with cross-functional teams to enhance product development and advertising campaigns.

Responsibilities

  • Conduct the independent review of advertising, promotional, communications and other materials.
  • Develop and implement regulatory strategies for promotion and advertising campaigns.
  • Serve as the primary liaison with FDA for assigned products on advertising and promotional compliance matters.
  • Identify product specific or therapeutic area A&P issues and work with other teams to propose and implement solutions.
  • Oversees and bears responsibility for successful implementation of regulatory strategic objectives and projects.

Requirements

  • Bachelor’s degree in Life Sciences from an accredited four-year college or university.
  • 1-3 Years experience in the following areas: Experience within pharmaceutical or medical device Regulatory Affairs.
  • Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
  • Knowledge and understanding of complex medical and scientific subject matter.
  • Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.

Benefits

  • Health insurance
  • Prevention and wellness programs
  • At least 14 weeks’ gender-neutral parental leave

Job title

Manager, Regulatory Affairs

Job type

Experience level

Junior

Salary

$122,250 - $176,583 per year

Degree requirement

Bachelor's Degree

Location requirements

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