Alexion Pharmaceuticals, Inc.
Director, Advertising and Promotional Compliance, US
Alexion Pharmaceuticals, Inc., Boston, Massachusetts, us, 02298
Overview
The Director, Advertising and Promotional Compliance, US, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will review and approve the regulatory content of materials created for product promotion, disease awareness and public affairs communications, engage business partners for strategic planning on promotional issues, develop processes and procedures for creation, review and approval of promotional material, and act as the primary liaison with the FDA on ad/promo regulatory issues concerning promotional materials. Responsibilities
Review US promotional, non-promotional, and scientific material; attend review meetings and provide regulatory guidance to cross-functional teams to ensure compliance with FDA advertising, promotion, and communication regulations for prescription drugs Serve as 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 creation, review and approval of advertising and promotional materials; establish standards and consistency across company brands Provide training support within the company on requirements for prescription drug promotion, 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 in product promotion and compliance; stay current with FDA enforcement actions and relevant conferences; communicate new regulatory standards to brand teams and management as appropriate Participate in and support ongoing initiatives to develop, implement, and improve the promotional review process Support and mentor ad/promo colleagues Essential Skills/Experience
Bachelor’s degree 7+ years of pharmaceutical industry experience in regulatory affairs and/or advertising and promotion Expertise in US advertising and promotional regulations and current regulatory environment Experience communicating and negotiating with OPDP and/or APLB Experience leading a team or with direct reports Experience with global standards for advertising and promotional compliance Excellent written and verbal skills and strong interpersonal skills Strong judgment in risk assessment Knowledge of industry compliance requirements and non-compliance examples/trends Ability to influence others and foster team collaboration Strong interpersonal, communication, and leadership skills Proficiency with Microsoft Office and promotional review software (e.g., Veeva Promomats and Veeva Medcomms) Office-based role expectations: ability to use a computer, communicate via phone/video/electronic messaging, problem solve, collaborate, and maintain standard business hours Desirable Skills/Experience
JD, PharmD or master’s degree preferred Equal Opportunity
We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will provide reasonable accommodation for applicants and employees with disabilities during application, interview, and job functions. Please contact us to request accommodation. About Alexion
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. We work in person typically three days per week but offer flexibility. We are a global biopharmaceutical company with an entrepreneurial spirit and a culture that supports patient-focused innovation, development, and collaboration. If this sounds like a team you want to be part of, we’d love to talk. Date posted
06-Oct-2025 Closing Date
19-Oct-2025 Seniority level
Director Employment type
Full-time Job function
Legal
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The Director, Advertising and Promotional Compliance, US, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will review and approve the regulatory content of materials created for product promotion, disease awareness and public affairs communications, engage business partners for strategic planning on promotional issues, develop processes and procedures for creation, review and approval of promotional material, and act as the primary liaison with the FDA on ad/promo regulatory issues concerning promotional materials. Responsibilities
Review US promotional, non-promotional, and scientific material; attend review meetings and provide regulatory guidance to cross-functional teams to ensure compliance with FDA advertising, promotion, and communication regulations for prescription drugs Serve as 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 creation, review and approval of advertising and promotional materials; establish standards and consistency across company brands Provide training support within the company on requirements for prescription drug promotion, 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 in product promotion and compliance; stay current with FDA enforcement actions and relevant conferences; communicate new regulatory standards to brand teams and management as appropriate Participate in and support ongoing initiatives to develop, implement, and improve the promotional review process Support and mentor ad/promo colleagues Essential Skills/Experience
Bachelor’s degree 7+ years of pharmaceutical industry experience in regulatory affairs and/or advertising and promotion Expertise in US advertising and promotional regulations and current regulatory environment Experience communicating and negotiating with OPDP and/or APLB Experience leading a team or with direct reports Experience with global standards for advertising and promotional compliance Excellent written and verbal skills and strong interpersonal skills Strong judgment in risk assessment Knowledge of industry compliance requirements and non-compliance examples/trends Ability to influence others and foster team collaboration Strong interpersonal, communication, and leadership skills Proficiency with Microsoft Office and promotional review software (e.g., Veeva Promomats and Veeva Medcomms) Office-based role expectations: ability to use a computer, communicate via phone/video/electronic messaging, problem solve, collaborate, and maintain standard business hours Desirable Skills/Experience
JD, PharmD or master’s degree preferred Equal Opportunity
We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will provide reasonable accommodation for applicants and employees with disabilities during application, interview, and job functions. Please contact us to request accommodation. About Alexion
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. We work in person typically three days per week but offer flexibility. We are a global biopharmaceutical company with an entrepreneurial spirit and a culture that supports patient-focused innovation, development, and collaboration. If this sounds like a team you want to be part of, we’d love to talk. Date posted
06-Oct-2025 Closing Date
19-Oct-2025 Seniority level
Director Employment type
Full-time Job function
Legal
#J-18808-Ljbffr