Associate Director, Advertising and Promotional Compliance, US

Are you ready to make a significant impact in the world of regulatory affairs

As the Associate Director Advertising and Promotion Compliance US you will be at the forefront of ensuring that our promotional materials meet global compliance standards and FDA regulations. You will serve as the Regulatory Affairs representative for assigned products and therapeutic areas reviewing and approving regulatory content for product promotion disease awareness and public affairs communications. Your strategic insights will guide business partners in planning and developing processes relevant to promotional materials. Are you prepared to be the primary liaison with the FDA on ad/promo regulatory issues

Accountabilities:

• Reviewing US promotional and non-promotional/scientific material attending review meetings and providing regulatory guidance to ensure adherence to global compliance standards and FDA regulations.
• Serving as the primary contact for communications with the OPDP and/or APLB for assigned products including timely preparation and submission of promotional materials under FDA Form 2253.
• Providing training support within Alexion on regulatory requirements for prescription drug promotion including sales training and compliance training for scientific conferences.
• Advising product development teams on advertising and promotion issues to facilitate strategic development of new products.
• Ensuring participant awareness of proposed and newly approved labeling changes.
• Communicating planned label updates to key partners in PRC and MRC providing guidance on implementation for assigned therapeutic areas.
• Collaborating with management and MLR Coordinator to develop processes for advertising and promotional materials; establishing standard methodologies across company products.
• Maintaining regulatory expertise in product promotion compliance by staying current with FDA enforcement actions and attending relevant conferences/seminars.
• Analyzing changes to the regulatory landscape with management and cross-functional partners determining internal impact and providing guidance to collaborators.
• Collaborating with ad/promo team and Reg Ops on novel submission processes.
• Participating/assisting in US labeling negotiations and FDA meetings as necessary.

Essential Skills/Experience:

• Bachelors Degree
• 5-7 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience
• Solid 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
• 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 indication
• Able to innovate analyze and solve problems with minimal supervisory input anticipating and identifying regulatory risks
• Solid understanding of business goals and common marketing concepts/tools including the internet and social media
• Proficiency using Microsoft Office software and promotional review software such as Veeva Promomats and Veeva Medcomms
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience:

• Advanced degree
• History of having direct reports or mentoring junior team members

When we put 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 individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca youll find a dynamic environment where innovation thrives. Our commitment to patients living with rare diseases drives us to push boundaries in research and development. With a rapidly expanding portfolio youll have the opportunity to grow your career while making a meaningful impact. Our culture fosters connections that inspire new ideas empowering you to explore diverse paths in marketing compliance and beyond. Supported by exceptional leaders and peers youll be part of a community dedicated to changing lives for the better.

Ready to embark on this exciting journey

Apply now to join our team!

Date Posted

Closing Date

Our 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