Sobi is hiring a Sobi Director, Regulatory Advertising and Promotion N.A. ...

Director, Regulatory Advertising and Promotion N.A. Full-time United States Location Compensation: USD 175,000 - USD 235,000 - yearly Company Description We encourage applicants from diverse backgrounds to apply. Rarely do candidates meet 100% of qualifications. Our team is dedicated to developing innovative therapies for rare disease patients. Our mission and culture inspire us daily. Benefits include: - Competitive compensation - Generous time off - Summer Fridays - Conference attendance opportunities - Work/life balance - Collaborative environment - Impact on ultra-rare disease patient treatments The Director of Regulatory Advertising and Promotion is responsible for strategic and tactical regulatory ad promo support across product lifecycles. As the internal subject matter expert on prescription drug advertising regulations, this role collaborates extensively with cross-functional teams to ensure compliant and effective communications. Reporting to the Global Head of Regulatory Advertising and Promotion, this role will review and approve US promotional communications for assigned products. The experienced regulatory professional will contribute to developing a best-in-class team. This position is remote-based with Eastern US time zone requirements and limited business travel. Key Responsibilities: - Lead regulatory review for assigned products - Review draft materials with cross-functional teams - Provide strategic direction and risk assessment - Partner with business to achieve objectives - Build relationships with regulatory authorities - Monitor FDA enforcement actions - Assess label impact on promotional strategy - Ensure promotional material compliance - Contribute to policy and procedure development - Develop stakeholder training Qualifications: Education: - Bachelor's Degree in scientific/healthcare field - Minimum 10 years biopharma experience - Advanced degree preferred Experience and Skills: - 8+ years pharmaceutical regulatory experience - 5+ years regulatory AdPromo expertise - Expert knowledge of FDA prescription drug regulations - Product launch support experience - Complex compliance advisory skills - Strong leadership and collaboration abilities - Clinical study design understanding - Drug development knowledge - Rare Diseases/Immunology/Hematology experience a plus - Strong interpersonal communication - Compliance and innovation culture fostering - Problem-solving capabilities Compensation and Total Rewards: - Competitive 401(k) match - Tuition and wellness reimbursements - Comprehensive medical/dental/vision package - Recognition awards - Base salary range: $175,000 - $235,000 - Bonus eligibility We are a global organization committed to rare disease solutions, seeking talented individuals passionate about making meaningful healthcare impacts. An Equal Opportunity Employer valuing diversity and inclusion. COVID-19 Policy: New hires must be fully vaccinated, with consideration for medical/religious accommodations.