Director, US Advertising and Promotional Compliance

AstraZeneca
Boston
Workplace: HybridFull timeUSD 193,281 - 289,922 annuallyFunction: Legal, Risk & ComplianceEducation: bachelorsSkills: ["Written and verbal communication","Interpersonal skills","Leadership","Risk assessment judgment","Team collaboration"]

Serve as therapeutic area lead and Regulatory Affairs representative for assigned products, ensuring promotional, non-promotional, and scientific materials meet FDA prescription drug advertising and communication requirements. Review and approve regulatory content, provide guidance to cross-functional teams, serve as primary liaison with FDA OPDP/APLB, and develop promotional review processes, training, and best-practice SOPs to maintain compliance across brand communications.

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AstraZeneca
AstraZeneca
3 days ago

Director, US Advertising and Promotional Compliance

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Last checked: 4 hours agoStatus: Live

Job Summary

Serve as therapeutic area lead and Regulatory Affairs representative for assigned products, ensuring promotional, non-promotional, and scientific materials meet FDA prescription drug advertising and communication requirements. Review and approve regulatory content, provide guidance to cross-functional teams, serve as primary liaison with FDA OPDP/APLB, and develop promotional review processes, training, and best-practice SOPs to maintain compliance across brand communications.
Location: Boston
Workplace: Hybrid
Employment Type: Full time
Job Function: Legal, Risk & Compliance
Seniority: Director level

Key Responsibilities

  • •Reviewing US promotional, non-promotional, and scientific materials and providing regulatory guidance to cross-functional teams to ensure adherence to FDA and compliance standards
  • •Serving as primary contact for communications with FDA’s Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products
  • •Developing processes and procedures, including best practices, working instructions, and/or SOPs, for creation, review, and approval of advertising and promotional materials
  • •Advising product development teams on advertising and promotion issues to support strategic development of new products
  • •Maintaining regulatory expertise by staying current with FDA enforcement actions and communicating new promotional standards to brand teams; supporting and mentoring ad/promo colleagues

Pay and Benefits

Salary: USD 193,281 - 289,922 annually
Equity and Bonus:Equity
Perks:Paid LeaveHealth InsuranceDentalVision

Key Requirements

  • •Bachelor’s degree
  • •7+ years in pharmaceutical industry regulatory affairs and/or advertising and promotion
  • •Expertise in US advertising and promotional regulations and the current regulatory environment
  • •Experience communicating and negotiating directly with OPDP and/or APLB
  • •Experience leading a team or having direct reports
Experience:Pharmaceutical industry
Education:Bachelor's
Skills:Written and verbal communicationInterpersonal skillsLeadershipRisk assessment judgmentTeam collaboration

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
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