Director, Regulatory Affairs, Advertising/Promotion

Essential Functions

• Oversees the regulatory review process for promotional materials in conformance with local regulatory requirements and company policy, and to ensure consistency with approved labeling.
• Provide advice and guidance on healthcare regulations applicable to the development and commercialization of BeOne's 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 various cross-functional teams, including promotional and medical review committees.
• Collaborate and participate on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.
• May provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical affairs, patient safety, legal, and healthcare compliance.
• Review and provide guidance on a wide range of promotional and non-promotional materials, including branded promotional materials, disease education/disease awareness campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, training materials, and reprint and publications plans.
• May provide regulatory advice on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with relevant regulations, guidance documents, and current enforcement trends.
• Advise and train on the Food, Drug and Cosmetic Act, FDA guidance documents, industry codes and standards (e.g., PhRMA, ICMJE, ACCME), and other laws and regulations applicable to the development and commercialization of pharmaceutical products.
• Assist with the development and implementation of policies and procedures related to healthcare compliance in the area of promotional and non-promotional communications and activities.
• Liaises and negotiates with regulatory authorities as needed for all aspects pertaining to promotional activities including resolution of key regulatory issues.
• Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
• Builds partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Recruits, develops, manages and mentors regulatory professionals and helps create a goal-oriented culture.

Skills and Experience

• Broad and comprehensive knowledge of commercial compliance requirements, including regulations and guidelines for promotional and non-promotional product communications.
• Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
• Direct experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
• Oncology and/or other relevant therapeutic area experience is preferred.
• Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges and the ability to balance short-term needs with long-term vision.
• 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 are a must, as are superior planning skills.
• The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.

Education Required

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, and a minimum of 5 years' experience in a Regulatory Ad/Promo capacity.

Supervisory Responsibilities

Expected to manage direct reports in the future.

Computer Skills

Proficiency in MS Office Suite applications and document management systems. Experience with using Veeva Vault preferred.