Director, Regulatory Affairs, Advertising/Promotion

BeiGene

1d • $176,000 - $236,000

About The Position

Reporting to the Head of Regulatory, Advertising/Promotion, this role provides regulatory oversight and strategic guidance on promotional and non-promotional communications and activities for assigned BeOne marketed products in North America. The position supports commercial, medical affairs, legal, healthcare compliance, and other business functions in the United States and Canada to ensure compliance with applicable regulatory requirements and guidelines and consistency with approved labeling.

The Director oversees regulatory review of promotional materials, advises on healthcare regulations, provides strategic guidance on commercial product labeling, and serves as a lead regulatory representative on cross-functional teams. The role also advises on promotional and non-promotional communications, healthcare professional and other stakeholder relationships, and relevant laws, regulations, guidance, and industry standards. It contributes to policies and procedures, liaises and negotiates with regulatory authorities, and supports business decision-making and cross-functional partnerships. The role may recruit, develop, manage, and mentor regulatory professionals; direct reports are expected in the future.

Requirements

• Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline.
• 10 or more years of experience in the biotech or pharmaceutical industry.
• At least 5 years of 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.
• Strong strategic skills, including identifying and addressing major strategic challenges and balancing short-term needs with long-term vision.
• Proven ability to deliver goals in a cross-functional team or partnership environment with a high level of professionalism.
• Ability to manage the financial and operating performance of a team.
• Excellent oral and written communication skills and superior planning skills.
• Detail-oriented, self-starting approach and comfort with broad responsibilities in an entrepreneurial, fast-paced environment.
• Proficiency in MS Office Suite applications and document management systems.

Nice To Haves

• Direct experience working with the FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch.
• Oncology and/or other relevant therapeutic area experience.
• Experience using Veeva Vault.

Responsibilities

• Oversee regulatory review of promotional materials in accordance with local regulatory requirements and company policy, ensuring consistency with approved labeling.
• Provide advice and guidance on healthcare regulations applicable to development and commercialization of BeOne products 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.
• Collaborate on cross-functional teams for product labeling, product development, medical affairs, and marketing.
• Provide healthcare regulatory advice across business functions, potentially including commercial, clinical development, medical affairs, patient safety, legal, and healthcare compliance.
• Review promotional and non-promotional materials and provide guidance on them, including branded promotional materials, disease education campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, training materials, and reprint and publications plans.
• Advise on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with applicable regulations, guidance, and enforcement trends.
• Advise and train on the Food, Drug and Cosmetic Act, FDA guidance documents, industry codes and standards, and other laws and regulations applicable to pharmaceutical product development and commercialization.
• Assist with developing and implementing policies and procedures for healthcare compliance in promotional and non-promotional communications and activities.
• Liaise and negotiate with regulatory authorities as needed on promotional activities, including resolving key regulatory issues.
• Apply functional expertise and business knowledge to solve problems and make decisions for the overall business.
• Build partnerships with stakeholders across functions to meet strategic business goals through sharing knowledge and expertise.
• Recruit, develop, manage, and mentor regulatory professionals and help create a goal-oriented culture.

Benefits

• Medical, dental, and vision coverage.
• 401(k).
• FSA/HSA.
• Life insurance.
• Paid time off.
• Wellness benefits.
• Annual bonus plan eligibility for non-commercial roles or incentive compensation plan eligibility for commercial roles.
• Eligibility for discretionary equity awards.
• Voluntary participation in the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Director