Director, US Advertising and Promotional Compliance

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.

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

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.