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Director, US Regulatory Affairs - Advertising and Promotion

Sanofi

Cambridge, MA
1 month ago

Job Description

Join Sanofi as a Director of US Regulatory Affairs and be at the forefront of shaping the future of medicine. Lead regulatory strategies and ensure compliance while working closely with cross-functional teams to drive innovation and improve patient outcomes.

Key Responsibilities

  • Provide direction and oversight for day-to-day activities for assigned products and departmental activities
  • Impart senior regulatory guidance and advice during issues management
  • Monitor regulatory environment and evaluate impact on business
  • Develop and implement regulatory strategies for marketed products
  • Establish key internal relationships with therapeutic product leaders
  • Assure alignment and consistency in policy application across products
  • Maintain product support relationships with FDA
  • Provide input into global labeling strategies for marketed drugs

Required Qualifications

  • 8+ years of experience within pharmaceutical or medical device Regulatory Affairs
  • Successful track record of relevant advertising & promotion regulatory experience
  • Experience managing others is preferred

Preferred Qualifications

  • Experience dealing effectively with cross-functional groups, including Medical, Legal, Marketing

Benefits & Perks

Comprehensive health and wellbeing benefitsAt least 14 weeks’ gender-neutral parental leaveOpportunities for career growth and development