[Hiring] Director, Regulatory Affairs, Advertising/Promotion @BeiGene

Role Description

Reporting to the Head of Regulatory, Advertising/Promotion, this role provides regulatory oversight and strategic guidance on promotional and non-promotional communications or activities for assigned BeOne marketed products in North America. This role supports our 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.

• 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.

Qualifications

• 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 (e.g., new competition, shifting market environment) 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 detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.

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.
• 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.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$176,000.00 - $236,000.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Benefits

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

Equal Opportunity Employer

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].