Senior Manager, Advertising and Promotional Compliance, US

Alexion Pharmaceuticals, Inc.; Boston (MA); Hybrid; USD 117,000 - 175,000; Full time

Job summary

AstraZeneca in Boston seeks a regulatory professional to lead US advertising and promotional compliance for assigned products, ensuring FDA-aligned, fair-balanced materials.

You will partner with medical, legal, regulatory, and cross-functional teams to drive compliant promo from concept to submission, manage OPDP interactions, and train staff on promotion requirements.

Qualifications

• Bachelor’s degree or PharmD post‑doc fellowship experience.
• Solid knowledge of US advertising and promotional regulations.
• Experience communicating with OPDP.
• Ability to assess regulatory risk and advise teams.
• Influence and lead cross-functional teams.
• Ability to meet critical timelines.
• Experience launching products or indications.
• Understanding of digital marketing concepts and tools.

Responsibilities

• Review US promotional and non-promotional/scientific material and provide regulatory guidance.
• Serve as primary contact with OPDP/APLB for assigned products, including FDA Form 2253 submissions.
• Provide regulatory training on prescription drug promotion as needed.
• Advise product development teams on advertising strategy for new products.
• Inform stakeholders about label changes and their promotional impact.
• Develop processes for creation, review, and approval of promo materials; standardize practices.
• Keep current with FDA actions and regulatory standards; attend conferences.
• Collaborate on submission processes with Reg Ops and MLR coordination.
• Assist in US labeling negotiations and FDA meetings.

Skills

Regulatory compliance

OPDP liaison

Risk assessment

Cross-functional collaboration

Communication skills

Leadership

Strategic advising

Timeline management

Product launches

Industry standards

Education

Bachelor’s degree

Job description

Are you ready to shape how we communicate life-changing science to patients and healthcare professionals—safely, compliantly, and with impact? This role supports the US advertising and promotional compliance strategy for assigned products, ensuring our external communications are scientifically rigorous, fair-balanced, and fully aligned with FDA requirements.

You will partner closely with cross-functional colleagues in medical, legal, regulatory, commercial, and regulatory operations to drive high-quality promotional and scientific materials from concept to submission. Can you anticipate regulatory risk and translate complex guidance into clear, actionable direction for teams? Your work will enable timely launches, confident market presence, and consistent, ethical engagement across a rapidly expanding portfolio serving people with significant unmet needs.

Accountabilities

• Reviewing US promotional and non-promotional/scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to global 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, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253
• As needed, providing training support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
• In collaboration with their manager, providing advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
• Ensuring stakeholder awareness of proposed and newly approved labeling changes
• Informing, reviewing and providing clear communication to all key stakeholders in both Promotional Review Committee (PRC) and Medical Review Committee (MRC) on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner
• In collaboration with their manager and the Medical Legal Regulatory (MLR) Coordinator, participating in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products
• Maintaining regulatory expertise in product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate
• Working with management and cross-functional partners to analyze changes to the regulatory landscape and determine any internal impact and communicate and provide guidance to all impacted key stakeholders
• Collaborate with ad/promo team and Reg Ops on creation and implementation of novel submission processes
• Participating/assisting in US labeling negotiations and FDA meetings as necessary

Essential Skills/Experience

• Bachelor’s degree
• 3 years of relevant experience or relevant PharmD post-doctoral Fellowship experience
• Solid knowledge of US advertising and promotional regulations
• Experience communicating and negotiating directly with OPDP
• Proven 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
• Proven ability to prioritize and meet critical business timelines
• Experience with launching new products and/or new indications
• Ability to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate
• Solid understanding of business goals and common marketing concepts/tools, including the internet and social media

Desirable Skills/Experience

• Advanced degree
• Experience with global standards for advertising and promotion compliance

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here, scientists, strategists, and storytellers come together to ensure our communications reflect the same integrity and ambition as our science. We operate with the focus of a nimble biotech and the reach of a global biopharma, bringing unexpected teams together to spark bold thinking that turns complex biology into meaningful patient impact. You will grow alongside leaders who value kindness as much as high standards, work with cutting-edge therapies addressing serious unmet needs, and see your decisions directly shape how transformative medicines reach those who need them most.

Own the standard for US promotional compliance and help bring breakthrough therapies to patients with clarity and integrity—take your next step with us today.

The annual base pay for this position ranges from $116,709 to $175,064. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

23-Oct-2026

Closing Date

29-Oct-2026

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.