Head of Global Regulatory, Advertising and Promotion

🕒 May 27

🍂 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

• Report to the Head of Global Regulatory Policy, Intelligence and Advertising & Promotion • 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 • Interaction with the FDA Office of Product Prescription and Drug Promotion • Provide regulatory advice and guidance on Advertising and Promotion for global promotional and non-promotional materials • Serve as an internal subject matter expert on FDA Advertising & Promotion issues • Foster a healthy business partnership environment with cross-functional stakeholders

🎯 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 knowledge of promotional and medical review supporting product communications

🏖️ 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