Director, Regulatory Affairs – Advertising/Promotion

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $176k - $236k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Provide regulatory oversight and strategic guidance on promotional and non-promotional communications and activities for assigned marketed products in North America • Support commercial, medical affairs, legal, healthcare compliance, and other business functions in the United States and Canada • Oversee the regulatory review process for promotional materials for compliance with local requirements, company policy, and approved labeling • Advise on healthcare regulations applicable to product development and commercialization in North America • Provide strategic guidance on commercial product labeling as part of the Labeling Working Group • Serve as lead regulatory representative on cross-functional promotional and medical review committees • Collaborate on product labeling, product development, medical affairs, and marketing teams • Advise business functions on healthcare regulatory matters • Review and guide promotional and non-promotional materials, including branded promotions, disease education campaigns, scientific communications, speaker programs, patient education, grants, sponsorships, training materials, and publication plans • Advise on relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities • Advise and train on the Food, Drug and Cosmetic Act, FDA guidance, industry codes and standards, and other applicable laws and regulations • Assist with developing and implementing healthcare compliance policies and procedures • Liaise and negotiate with regulatory authorities regarding promotional activities and resolve key regulatory issues • Integrate functional expertise with business knowledge to solve problems and support business decisions • Build partnerships with stakeholders across functions to achieve strategic business goals • Recruit, develop, manage, and mentor regulatory professionals • Expected to manage direct reports in the future

🎯 Requirements

• Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline • 10+ years of experience in the biotech or pharmaceutical industry • Minimum of 5 years’ experience in a Regulatory Ad/Promo capacity • Broad and comprehensive knowledge of commercial compliance requirements, including regulations and guidelines for promotional and non-promotional product communications • Ability to develop and implement commercial regulatory strategy and manage complex negotiations with internal and external stakeholders • Very strong strategic skills, including creativity and effectiveness in identifying and addressing major strategic challenges • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism • Proficient ability in managing the financial and operating performance for a team • Excellent oral and written communication skills • Superior planning skills • Detailed-oriented, self-starter, and comfortable with broad responsibilities in an entrepreneurial, fast-paced environment • Proficiency in MS Office Suite applications and document management systems • Direct experience working with FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch preferred • Oncology and/or other relevant therapeutic area experience preferred • Experience using Veeva Vault preferred

🏖️ Benefits

• Annual bonus plan or incentive compensation plan eligibility • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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