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

BeiGene

122d • $205,600 - $275,600

About The Position

This role is the head of Promotional Regulatory, and provides regulatory leadership, support, oversight, and strategic guidance on promotional and non-promotional communications or activities for BeOne Medicines marketed products in North America with some activity globally. This role supports our commercial, medical affairs, legal, healthcare compliance and other business functions primarily in the United States with some activities globally to ensure compliance with applicable regulatory requirements and guidelines, and consistency with approved labeling. The role also is expected to work closely with our in-house commercial, legal and regulatory colleagues in Europe, China and other regions to ensure global coordination of promotional and non-promotional product communications/activities and ensure compliance with company policies and international guidelines.

Requirements

• Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline.
• At least 12+ years of experience in regulatory affairs, in advertising/promotion, labeling or related discipline.
• 5 years of supervisory/management experience, or the equivalent combination of education and relevant experience.
• Broad and comprehensive knowledge of commercial compliance requirements, including regulations and guidelines for promotional and non-promotional product communications.
• 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.
• Track record of building and leading high-performance teams.
• Excellent oral and written communication skills.
• Detailed-oriented, a self-starter, and comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
• Ability to work in a team environment with all levels of cross functional partners.

Responsibilities

• 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 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 various cross-functional teams, including promotional and medical review committees.
• Supports direct reports who may attend cross-functional team meetings.
• Collaborate and participate on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.
• 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.
• 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.
• Review and advise on healthcare regulatory matters in BeOne’s external communications, such as scientific journal articles, abstracts, presentations at medical conferences, press releases, and investor presentations.
• 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 senior 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.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree