Director, Regulatory Affairs – Advertising/Promotion
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Job Description
Regulatory affairs director overseeing FDA-compliant advertising and promotional communications for BeOne’s pharmaceutical products. Advising cross-functional US and Canadian commercial, medical, legal, and compliance teams.
Responsibilities:
- 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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