Associate Director, Advertising and Promotional Compliance, US

About the role

The Associate Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas. They will review and approve regulatory content of materials created for product promotion, disease awareness, and public affairs communications. The role involves strategic planning with business partners on product promotion issues and developing processes and procedures for the creation, review, and approval of promotional materials. The Associate Director may also act as the primary liaison with the FDA on ad/promo regulatory issues.

Responsibilities

• Review US promotional and non-promotional/scientific materials, attend review meetings, and provide regulatory guidance to cross-functional teams to ensure adherence to global compliance standards and 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, including timely preparation and submission of promotional materials under FDA Form 2253.
• Provide training support on regulatory requirements for prescription drug promotion, including sales and compliance training for scientific conferences.
• Advise product development teams on advertising and promotion issues to facilitate strategic development of new products.
• Ensure stakeholder awareness of proposed and newly approved labeling changes and communicate their impact on promotional and medical materials.
• Provide guidance on appropriate implementation of label updates, including ISI updates, for assigned therapeutic areas.
• Participate in developing processes and procedures for the creation, review, and approval of advertising and promotional materials, establishing best practices for consistency across company products.
• Maintain regulatory expertise by staying current with FDA enforcement actions and attending relevant conferences/seminars; communicate new regulatory standards to brand teams and management.
• Work with management and cross-functional partners to analyze changes in the regulatory landscape, determine internal impact, and provide guidance to key stakeholders.

Requirements

• Bachelor’s Degree.
• 5 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience.
• Knowledge of U.S. advertising and promotional regulations.
• Experience communicating and negotiating directly with OPDP and/or APLB.
• Experience with global standards for advertising and promotion compliance.
• Knowledge of industry compliance requirements, non-compliance examples, and trends.
• Experience with launching new products and/or new indications.
• Solid understanding of business goals and common marketing concepts/tools, including the internet and social media.
• Proficiency using promotional review software, such as Veeva Promomats and Veeva Medcomms.

Desirable Skills

• Advanced degree.
• 7 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience.
• History of having direct reports or mentoring junior team members.
• Proven track record practicing sound judgment as it relates to risk assessment.
• Strong interpersonal, communication, and leadership skills.
• Proven ability to prioritize and meet critical business timelines.

Work Environment

Alexion embraces an in-person working model, with employees working a minimum of three days per week from the office to foster connection, collaboration, and innovation. Flexibility is balanced with the expectation of in-office presence. The role offers a unique and ambitious environment within the global biopharmaceutical landscape, with a focus on patient-centric work, entrepreneurial spirit, and tailored development programs.

Pay

The annual base pay for this position ranges from $150,000 to $200,000. The role is eligible for various incentives, including short-term incentive bonuses and equity-based awards.

Benefits

• Qualified retirement programs.
• Paid time off (vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with applicable plans.