Associate Director, Advertising and Promotional Compliance, US
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Job Location:
Boston, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Are you ready to shape how we communicate life-changing science to patients and healthcare professionalssafely compliantly and with impact This role leads 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 advertisingpromotion 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 managerprovidingadvice 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) Coordinatorparticipatingin 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:
Bachelors Degree
Minimum 5 years of relevant experienceand/or relevant PharmD post-doctoral Fellowship experience
5 years of U.S. advertising and promotional regulations
Experience communicating and negotiating directly with OPDP and/orAPLB
Experience with global standards for advertising and promotion compliance
Proventrack recordpracticing 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
Experience with launching new products and/or newindication
Solid understanding of business goals and common marketing concepts/tools including the internet and social media
Proficiencyusing promotional review software such as VeevaPromomatsand VeevaMedcomms
Desirable Skills/Experience:
Advanced degree
History having direct reportsor mentoring junior team members
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 integritytake your next step with us today.
The annual base pay for this position ranges from $150000 to $225000 . Our positions offer eligibility for various incentivesan 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
13-Mar-2026Closing Date
30-Mar-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
