Director, US Advertising and Promotional Compliance
About The Position
The Director, US Advertising and Promotional Compliance, serves as the therapeutic area lead and Regulatory Affairs representative for assigned products. The role reviews and approves regulatory content for product promotion, disease awareness, and public affairs communications; partners with business teams on strategic promotional planning; and helps develop processes for creating, reviewing, and approving promotional materials. The Director is also the primary liaison with the FDA on advertising and promotional regulatory issues concerning promotional materials. The position leads US promotional compliance activities, provides regulatory guidance to cross-functional teams, supports training and product development, and maintains expertise in FDA promotional regulations and enforcement. It also contributes to improvements in the promotional review process and supports and mentors advertising and promotional compliance colleagues. The role follows a flexible in-person model, with an average minimum of three days per week in the office. The annual base pay ranges from $193,281 to $289,922. The position is eligible for short-term incentive bonuses and equity-based awards. Benefits include qualified retirement programs, paid time off, and health, dental, and vision coverage, subject to applicable plan terms.
Requirements
- Bachelor’s degree.
- At least 7 years of pharmaceutical industry experience 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 having direct reports.
- Experience with global standards for advertising and promotional compliance.
- Excellent written and verbal communication skills and strong interpersonal skills.
- Consistent track record of sound judgment in risk assessment.
- Knowledge of industry compliance requirements and examples and trends in non-compliance.
- Demonstrated ability to influence others and foster team collaboration.
- Strong leadership skills.
Nice To Haves
- JD, PharmD, or master’s degree preferred.
Responsibilities
- Review US promotional, non-promotional, and scientific materials; attend review meetings; and provide regulatory guidance to cross-functional teams on compliance standards and applicable FDA regulations.
- Serve as the primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products.
- Develop processes and procedures for creating, reviewing, and approving advertising and promotional materials, including best practices, work instructions, and/or SOPs to establish consistent standards across company brands.
- Provide training support within Alexion, as needed, on prescription drug promotion requirements, including sales and compliance training for scientific congresses and conferences.
- Advise product development teams on advertising and promotion issues to support strategic development of new products.
- Maintain regulatory expertise by monitoring FDA enforcement actions and attending relevant conferences and seminars; communicate new regulatory standards to brand teams and management as appropriate.
- Participate in and support key initiatives, including development, implementation, and continued improvement of the promotional review process.
- Support and mentor advertising and promotional compliance colleagues.
Benefits
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
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What This Job Offers
Job Type
Full-time
Career Level
Director
