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Associate Director, Promotional Regulatory Affairs

Location Wilmington, Delaware, United States Gaithersburg, Maryland, United States Job ID R-082517 Date posted 05/27/2020

The BioPharmaceuticals Business Unit (BBU) creates and executes meaningful therapeutic area and product strategies that are focused on addressing the unmet needs of patients around the world. We are committed to changing the course of medicine and bringing innovative therapies to enhance the quality of life for our patients. The BBU integrates commercial, market access, medical, digital, and corporate functions to drive scientific development and commercial excellence in the core areas of respiratory, cardiovascular, renal and diabetes disease.

This position requires that the successful applicant possess knowledge of FDA promotional regulations to support assigned brand(s).  This position will work independently, with minimal supervision, with a cross-functional review team and provide regulatory guidance to help business teams deliver initiatives that comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products.  Responsible for review and approval of promotional materials as are required through the AstraZeneca Approval Process (AZAP).   Represent AstraZeneca to regulatory authorities for assigned brand(s), and projects, as appropriate.  Provide promotional regulatory review support to the Brand team in accordance with the Brand strategy, and current interpretation of FDA regulations and associated guidance.  Leads/participates on special projects and/or PRA Skill Center Initiatives/Centers of Expertise.

Major Responsibilities:

  • Reviews, evaluates, and approves promotional materials and commercial activities within established frames to ensure compliance with regulations, internal and external guidelines.
  • Acts independently in applying regulatory and therapeutic area knowledge with a solution- oriented approach to meet marketing objectives while minimizing regulatory risk.
  • Responsible for communications with OPDP, including submission of advisory comments, preparing or responding to competitor complaints, and responding to enforcement letters.
  • Provides promotional regulatory input into product labeling strategy, including attending key FDA meetings that have promotional implications for commercial teams.
  • Provides promotional regulatory advice and support from study design to labeling though successful launch, including new products, data, indications and ISI updates.
  • Provides promotional regulatory input on target claims statements and target product profiles including identifying risks and contingency plans.
  • Monitors regulatory environment for therapeutic area and maintains awareness of competitor promotional activities.
  • Actively participates in training and other initiatives of the PRA Skill Center to help ensure continuous improvement in processes.
  • Adheres to corporate policies and conducts business in a professional and complaint manner. 

Essential Requirements:

  • Degree in pharmacy, pharmacology or other life science
  • 5+ years experience in drug regulatory affairs or related pharmaceutical field
  • Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
  • Working knowledge of the drug development process
  • Experience working in a team-based environment
  • Collaborative mindset
  • Effective verbal and written communication and influencing skills
  • Exemplary compliance ethics and high concern for standards
  • Strategic and analytic thinking and decision-making skills
  • Ability to manage a diverse workload and quickly adjust to changing business priorities
  • Ability to manage, coordinate, and execute on projects independently with minimum supervision

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.