Senior Manager, Advertising and Promotional Compliance, US

Alexion; Boston (MA); On-site; USD 117,000 - 175,000; Full time

Job summary

AstraZeneca in the United States is seeking a regulatory advertising and promotions professional to oversee US promotional compliance for assigned products, ensuring materials are fair-balanced and FDA-compliant. You will collaborate with medical, legal, regulatory, commercial, and regulatory operations to translate guidance into actionable directions.

Key responsibilities include reviewing materials, serving as the primary OPDP contact, guiding label updates, and helping develop processes for

Qualifications

• Bachelor’s degree required.
• 3 years of relevant experience or PharmD post-doctoral fellowship.
• Strong knowledge of US advertising and promotional regulations.
• Experience communicating with OPDP.
• Ability to assess regulatory risk and advise management.
• Knowledge of industry compliance trends.

Responsibilities

• Review US promotional and non-promotional materials for FDA compliance.
• Serve as primary contact for OPDP/APLB for assigned products.
• Provide regulatory training on promotion requirements.
• Advise product development teams on advertising and promotion issues.
• Communicate labeling changes to stakeholders and ensure proper implementation.
• Develop processes for the creation, review and approval of promotional materials.
• Stay current with FDA enforcement actions and regulatory standards.

Skills

Regulatory compliance knowledge

OPDP negotiation experience

Risk assessment

Cross-functional collaboration

Influence and leadership

Prioritization and deadlines

Product launches experience

Analytical problem solving

Marketing concepts/tools (internet & 社

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 reviewmeetingsandprovidingregulatory guidance to the cross-functional team responsible for ensuring adherence to global compliance standards and FDA regulationspertaining toprescription drug advertising,promotion, and communication as applicable
• Servingas primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/orAdvertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for thetimelypreparation and submission of promotional materials under cover of FDA Form 2253
• As needed, providingtraining 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,providingadvice to product development teams on advertising and promotion issues tofacilitatethe strategic development of new products
• Ensuringstakeholderawareness of proposed and newly approved labeling changes
• Informing, reviewingand providingclear 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 andtheMedical Legal Regulatory (MLR) Coordinator,participatingin developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices toestablishstandards and consistency across company products
• Maintaining regulatoryexpertisein product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars.Communicate new regulatory standardspertaining toprescription drug promotion to brand teams and management, as appropriate
• Workingwith management and cross-functional partners to analyze changes to the regulatory landscape anddetermineany internal impact and communicate and provide guidance to all impacted key stakeholders
• Collaborate with ad/promo team and Reg Ops on creation and implementationof novelsubmission processes
• Participating/assistingin 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 individualflexibility. 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.