Head of Global Regulatory Advertising and Promotion

🕒 March 26

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $260k - $290k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

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.

📋 Description

• 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