Director, Regulatory Affairs – Advertising/Promotion

BeOne Medicines

. Provide regulatory oversight and strategic guidance on promotional and non-promotional communications and activities for assigned marketed products in North America .

Posted 11/10/2026full-timeRemote • United StatesLead💰 $176,000 - $236,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory oversight and strategic guidance for promotional and non-promotional communications in the biotech and pharmaceutical industries. Proficient in managing complex negotiations and developing commercial regulatory strategies while ensuring compliance with healthcare regulations.

Highest-signal resume keywords

Regulatory OversightCommercial Compliance RequirementsFDA GuidanceStrategic Communication SkillsTeam Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Ad/Promo ExperienceCommercial Regulatory Strategy DevelopmentNegotiation SkillsFinancial Performance ManagementDetailed-Oriented

Soft Skills

CreativityProfessionalismPlanning SkillsSelf-StarterCollaboration

Tools & Technologies

MS Office SuiteDocument Management SystemsVeeva Vault

Industry Keywords

Biotech IndustryPharmaceutical IndustryHealthcare ComplianceOncology ExperienceFood, Drug and Cosmetic Act

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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