Full-Time

Director – Regulatory Affairs

Confirmed live in the last 24 hours

Azurity Pharmaceuticals

Azurity Pharmaceuticals

201-500 employees

Pharmaceuticals for diverse medical conditions


Senior

Burlington, MA, USA

Requirements
  • Bachelor’s degree in Life Science or other related discipline
  • At least 10 years’ experience in Regulatory Affairs with direct experience in Labeling and Advertising/Promotional review
Responsibilities
  • Provide commercial regulatory strategy and leadership for promotional materials
  • Advise internal teams and management on regulations, guidance, and industry best practices related to product labeling and advertising/promotional components
  • Perform regulatory review of advertising and promotional materials
  • Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies
  • Lead the MLR (medical, legal, regulatory) review committee for advertising and promotional components
  • Create/revise SOP’s and Work Instructions
  • Continuously monitor the regulatory environment for new regulations
  • Recruit, develop, and act as an advisor and coach to direct reports and junior members of the regulatory team

Azurity Pharmaceuticals

Azurity Pharmaceuticals

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Azurity Pharmaceuticals specializes in providing innovative, high-quality medicines, including dose-form innovations for cardiovascular, central nervous system, endocrine, gastro-intestinal, anti-infective, and oncology conditions, benefiting millions of people.

Company Stage

Series B

Total Funding

$182.2M

Headquarters

Woburn, Massachusetts

Founded

2000

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

10%

2 year growth

59%