Senior Director, Regulatory Affairs, Head of Regulatory Advertising and Promotion

Role Summary

Senior Director, Regulatory Affairs, Head of Regulatory Advertising and Promotion — BeOne Medicines. Leads Promotional Regulatory with regulatory leadership, support, oversight, and strategic guidance on promotional and non-promotional communications for BeOne Medicines in North America and globally as needed.

Responsibilities

• Oversees the regulatory review process for promotional materials in conformance with local regulatory requirements and company policy, ensuring consistency with approved labeling.
• Provide advice and guidance on healthcare regulations applicable to the development and commercialization of BeOne‚Äôs medicines and product candidates in North America.
• Provide strategic guidance on commercial product labeling as part of the Labeling Working Group.
• Serve as the lead regulatory representative on cross-functional teams, including promotional and medical review committees; support direct reports who may attend meetings.
• Collaborate on cross-functional teams for product labeling, product development, medical affairs, and marketing.
• Provide advice on healthcare regulatory matters across business functions (commercial, clinical development, medical affairs, patient safety, legal, healthcare compliance).
• Review and guide a wide range of promotional/non-promotional materials (branded materials, disease education, scientific communications, speaker programs, patient education materials, grants, trainings, publications).
• Provide regulatory advice on relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, per regulations and guidance.
• Review and advise on external communications (journal articles, abstracts, conference presentations, press releases, investor presentations).
• Advise and train on relevant laws and guidelines (FD&C Act, FDA guidance, PhRMA, ICMJE, ACCME) and regulatory requirements.
• Assist with development/implementation of policies for healthcare compliance in promotional/non-promotional communications.
• Liaise and negotiate with regulatory authorities on promotional activities and issue resolution.
• Integrate functional expertise with business knowledge to solve problems and make decisions.
• Build partnerships with senior stakeholders to meet strategic goals through knowledge sharing.
• Recruit, develop, manage, and mentor regulatory professionals and foster a goal-oriented culture.

Supervisory Responsibilities

• Manage direct reports involved in promotional/publication strategies and operational activities for approved assets and development programs.

Education/Experience Required

• Bachelor‚Äôs degree (BS/BSc or BA) in a scientific or health-related discipline; at least 12+ years in regulatory affairs related to advertising/promotion, labeling, or related discipline.
• 5 years of supervisory/management experience, or equivalent combination of education and relevant experience.
• Broad knowledge of commercial compliance requirements for promotional and non-promotional product communications.
• Strong strategic skills, ability to address major strategic challenges, balance short-term and long-term priorities.
• Proven ability to deliver goals within cross-functional teams and maintain professionalism.
• Financial and operating management capability for a team; track record of building/high-performing teams.
• Excellent oral and written communication, superior planning skills, detail-oriented, self-starter, able to handle broad responsibilities in a fast-paced environment.
• Ability to work effectively with all levels of cross-functional partners.

Skills

• Regulatory leadership in advertising and promotion.
• Cross-functional collaboration and program leadership.
• Regulatory compliance knowledge (FDA/FD&C Act, industry codes and standards).
• Strategic labeling and communications review.
• Policy development and training delivery.
• Regulatory negotiations and issue resolution.

Education

• See Education/Experience Required above.

Additional Requirements

• Proficiency in MS Office Suite and document management systems.