Head of Global Regulatory Advertising and Promotion
Sobi - Swedish Orphan Biovitrum AB (publ)
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $260,000 - $290,000 per year
Job Level
About the role
- Head of Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Policy
- Lead and direct post-marketing regulatory activities pertaining to marketing of Sobi products
- Responsible for regulatory review and approval of U.S. promotional, corporate, and medical communications
- Lead interactions with the FDA Office of Product Prescription and Drug Promotion
- Provide regulatory advice and guidance throughout the product life cycle
- Demonstrate leadership as the Regulatory Advertising and Promotion Leader
- Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation
- Develop and leads departmental strategic initiatives
Requirements
- Minimum BS in Scientific discipline
- Advanced scientific degree (PhD, MD, PharmD, etc) or Juris Doctor preferred
- Minimum of 15 years of experience in pharmaceutical industry
- Minimum of 5 years as a regulatory Ad & Promo professional
- Experience in Rare Diseases, Hematology and/or Oncology a plus
- Expert knowledge of advertising promotion regulations and FDA Guidance documents
- Advanced experience with promotional and medical review supporting product communications
- Proficient in the use of AI digital tools
Benefits
- Competitive compensation for your work
- Generous time off policy
- Summer Fridays
- Opportunity to broaden your horizons by attending popular conferences
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory reviewpost-marketing regulatory activitiesadvertising promotion regulationsFDA Guidance documentspromotional reviewmedical reviewregulatory risk assessmentstrategic initiativesproduct life cycle managementexperience in Rare Diseases
Soft Skills
leadershipstrategic partnershipcommunicationguidanceadvice
Certifications
BS in Scientific disciplinePhDMDPharmDJuris Doctor