Director, Regulatory Advertising and Promotion

November 25

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $175k - $235k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Sobi - Swedish Orphan Biovitrum AB (publ)

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle. • Collaborates extensively with cross-functional teams to ensure that promotional communications are compliant and meet business objectives. • Serves as the primary liaison with the FDA’s office of prescription Drug Promotion (OPDP). • Reports to the Global Head of Regulatory Advertising and Promotion and accounts for the review and approval of US promotional and non-promotional communications of assigned product(s). • Contributes to the ongoing development of a best-in-class Regulatory Advertising and Promotion team.

🎯 Requirements

• Minimum Bachelor’s Degree in a scientific or healthcare-related field • Minimum 10 years of related biopharma experience • Advanced scientific degree (MD, PharmD, PhD) or Juris Doctor with a minimum of 8 years related biopharma experience preferred • Minimum of 8 years of regulatory experience in the pharmaceutical industry • Minimum of 5 years of regulatory AdPromo experience • Expert knowledge of FDA prescription drug regulations, policies, guidances, and enforcement trends • Experience in supporting product launch required • DTC broadcast ads experience highly desirable • Strong leadership skills including ability to collaborate across all levels of the organization in achieving sound business decisions • Good understanding of clinical study design and statistical analyses in assessment of proposed promotional claims • Understanding of drug development and labeling • Experience in Rare Diseases, Immunology, and/or Hematology a plus • Strong interpersonal and communication skills with the ability lead with or without direct authority. • Foster a culture of compliance, innovation, accountability, and continuous learning • Ability to innovate, analyze, and solve problems.

🏖️ 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