Director, Regulatory Affairs – Advertising/Promotion

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide oversight on regulatory matters and strategic direction for promotional and non-promotional communications related to marketed products in North America.

• Assist commercial, medical affairs, legal, healthcare compliance, and other business units across the United States and Canada.

• Supervise the regulatory review process for promotional materials to ensure adherence to local regulations, company policies, and approved labeling.

• Offer advice on healthcare regulations pertinent to product development and commercialization in North America.

• Provide strategic insights on commercial product labeling as part of the Labeling Working Group.

• Act as the primary regulatory representative on cross-functional promotional and medical review committees.

• Collaborate with teams focused on product labeling, development, medical affairs, and marketing.

• Counsel business functions on matters related to healthcare regulations.

• Review and provide guidance on promotional and non-promotional content, including branded promotions, disease education campaigns, scientific communications, speaker programs, patient education, grants, sponsorships, training materials, and publication strategies.

• Offer advice regarding interactions with healthcare professionals, patients, managed care entities, advocacy groups, and government organizations.

• Provide training and insights on the Food, Drug, and Cosmetic Act, FDA guidance, industry codes and standards, and other relevant laws and regulations.

• Assist in the creation and implementation of healthcare compliance policies and procedures.

• Negotiate and liaise with regulatory authorities concerning promotional activities and resolve significant regulatory challenges.

• Integrate functional expertise with business acumen to address challenges and support decision-making.

• Foster partnerships with stakeholders across various functions to meet strategic business objectives.

• Recruit, develop, manage, and mentor regulatory professionals.

• Expected to oversee direct reports in the future.

⛳️ Requirements

• Bachelor’s degree (BS/BSc or BA), ideally in a scientific or health-related field.

• Over 10 years of experience in the biotech or pharmaceutical sectors.

• At least 5 years of experience in a Regulatory Advertising/Promotion role.

• Extensive and thorough understanding of commercial compliance requirements, including regulations and guidelines for promotional and non-promotional product communications.

• Capability to formulate and execute commercial regulatory strategies and manage complex negotiations with both internal and external stakeholders.

• Strong strategic skills, including creativity and effectiveness in recognizing and tackling significant strategic challenges.

• Demonstrated ability to achieve objectives within a cross-functional team or partnership setting, maintaining a high degree of professionalism.

• Proficient in managing the financial and operational performance of a team.

• Exceptional oral and written communication abilities.

• Superior planning competencies.

• Detail-oriented, self-motivated, and capable of managing broad responsibilities in a dynamic, entrepreneurial environment.

• Proficient in MS Office Suite applications and document management systems.

• Direct experience with the FDA’s Office of Prescription Drug Promotion or the Advertising and Promotional Labeling Branch is preferred.

• Experience in oncology and/or other relevant therapeutic areas is preferred.

• Familiarity with Veeva Vault is preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan or incentive compensation plan.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance.

• Paid Time Off.

• Wellness programs.