Director, US Advertising and Promotional Compliance
AstraZeneca
Summary
The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials.
Job description
Accountabilities
- Reviewing US promotional, non-promotional, and scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicable
- Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products
- Developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials: Developing best practices, working instructions and/or SOPs to establish standards and consistency across company brands
- As needed, providing training support within Alexion on requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific congresses and conferences
- Advising product development teams on advertising and promotion issues to facilitate the strategic development of new products
- Maintaining regulatory expertise in product promotion and compliance by keeping current with issued FDA enforcement actions and through attendance of relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate
- Participating in and supporting ongoing key initiatives including the development, implementation, and continued improvement of promotional review process
- Supporting and mentoring ad/promo colleagues
Essential Skills/Experience
- Bachelor's degree
- 7+ years pharmaceutical industry in regulatory affairs and/or advertising and promotion
- Expertise in US advertising and promotional regulations and the current regulatory environment
- Experience communicating and negotiating directly with OPDP and/or APLB
- Experience leading a team or experience having direct reports
- Experience with global standards for advertising and promotional compliance
- Excellent written and verbal skills and strong interpersonal skills
- Consistent track record practicing sound judgment as it relates to risk assessment
- Knowledgeable on industry compliance requirements and non-compliance examples and trends
- Demonstrated ability to influence others and foster team collaboration
- Strong interpersonal, communication, and leadership skills
Desirable Skills/Experience
- JD, PharmD or master's degree preferred
Requirements
- Bachelor's degree
- 7+ years pharmaceutical industry in regulatory affairs and/or advertising and promotion
- Expertise in US advertising and promotional regulations and the current regulatory environment
- Experience communicating and negotiating directly with OPDP and/or APLB
- Experience leading a team or experience having direct reports
- Experience with global standards for advertising and promotional compliance
- Excellent written and verbal skills and strong interpersonal skills
- Consistent track record practicing sound judgment as it relates to risk assessment
- Knowledgeable on industry compliance requirements and non-compliance examples and trends
- Demonstrated ability to influence others and foster team collaboration
- Strong interpersonal, communication, and leadership skills
- JD, PharmD or master's degree preferred
Benefits
- Retirement Programs
- Paid Time Off
- Health Coverage
- Dental Coverage
- Vision Coverage
- Short-Term Incentive Bonuses
- Equity-Based Awards
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.