Director, US Advertising and Promotional Compliance

AstraZeneca•Boston, MA

5d•$193,281 - $289,922•Hybrid

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 the regulatory content of product promotion, disease awareness, and public affairs communications; engages business partners in strategic planning for product-promotion issues; and contributes to processes and procedures for creating, reviewing, and approving promotional material. The Director is also the primary liaison with the FDA on advertising and promotional regulatory matters concerning promotional materials. The role provides regulatory guidance to cross-functional teams, communicates with the FDA’s Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB), and supports training, product development, and ongoing improvements to promotional review processes. It also helps maintain regulatory expertise, shares relevant regulatory developments with brand teams and management, and supports and mentors advertising and promotional compliance colleagues. The position is based on an in-person working model averaging at least three days per week in the office, with flexibility. The annual base pay ranges from $193,281 to $289,922. The position is eligible for short-term incentive bonuses and equity-based awards for salaried roles. 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 to support compliance with applicable standards and FDA regulations for prescription drug advertising, promotion, and communications.
Serve as the primary contact for communications with OPDP and/or 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 standards and consistency across company brands.
Provide training support within Alexion, as needed, on prescription drug promotion requirements, including sales and compliance training in preparation for scientific congresses and conferences.
Advise product development teams on advertising and promotion issues to facilitate strategic development of new products.
Maintain regulatory expertise in product promotion and compliance 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.