Associate Director, Global Regulatory Affairs - Ad / Promo

Bion Environmental Technologies Inc

Cambridge, US
Base: $166,000pyear to $203,000pyear; bonus/equity...
On-site
Review and approval of us promotional materials
Regulatory compliance/strategy
Interactions with fda opdp and aplb
The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications of assigned brand(s)

Job Summary

  • The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications of assigned brand(s).
  • This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, Legal, Global Regulatory Affairs, Labeling and Compliance for the purpose of providing regulatory advice and guidance.
  • BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.

Matching Summary

The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications of assigned brand(s).

Salary

Base: $166000/year to $203000/year; Bonus/Equity: annual bonus & equity (variable); Benefits: benefits

Skills & Requirements

Must-have

  • review and approval of US promotional materials
  • regulatory compliance/strategy
  • interactions with FDA OPDP and APLB
  • internal subject matter expert on FDA Advertising & Promotion

Nice-to-have

  • experience in Oncology is a plus
  • stream-lined workflows and encourage proficient practice

Key Requirements

  • Minimum of 8 years experience in the pharmaceutical industry
  • minimum of 5 years in regulatory affairs
  • Expert knowledge of advertising promotion regulations
  • Solid experience with promotional and medical review

Work Rights

Not specified

Tailored Resume

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