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AstraZeneca

Global pharmaceutical company developing prescription medicines

Associate Director - Promotional Regulatory Affairs, Bbu

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeGaithersburg, MD, USA

About the Job

Requirements

  • A bachelor's degree in pharmacy, pharmacology, life science, or a related science field is required.
  • At least five years of experience in drug or biologic regulatory affairs, or a related pharmaceutical or biotechnology field, is required.
  • Working knowledge of FDA promotional regulations and the ability to apply that knowledge when reviewing diverse promotional materials and audiences are required.
  • Working knowledge of the drug development process is required.

Responsibilities

  • Work with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that comply with applicable laws, rules, and regulations governing advertising and promotion of pharmaceutical products in the United States.
  • Lead the review and adjudication of promotional materials required through the AstraZeneca Approval Process (AZAP).
  • Represent AstraZeneca to regulatory authorities for assigned brands and projects, as appropriate.
  • Provide promotional regulatory advice and support to cross-functional partners in accordance with their strategies and objectives, and provide current promotional regulatory affairs interpretations and recommendations related to FDA promotional regulations and associated guidance.
  • Ensure efficient and effective regulatory review and risk assessment of promotional material for healthcare professionals, consumers, managed markets, print, broadcast and electronic media, sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and other materials requiring review through AZAP.
  • Conduct reviews within established timelines and meet expedited requests as priorities and workload allow.
  • Assist in developing and implementing innovative regulatory strategies, including risk identification and contingency planning.
  • Participate with Commercial Operations, medical, legal, and regulatory reviewers, and asset owners in asset prioritization and consultation meetings, as requested.
  • Provide guidance to the business to assist in implementing brand strategies, as requested.
  • Develop promotional regulatory affairs guidance and job aids on relevant topics for departmental and cross-functional use, as appropriate.
  • Manage requests for FDA advisory review of materials and adjudicate incoming and outgoing competitor product complaints, as appropriate.
  • Help evaluate brand regulatory training needs and develop and deliver training in partnership with the Internal and/or External Training Initiative or Promotional Regulatory Affairs Skill Center.
  • Monitor regulatory agency activities, new guidance, and emerging regulatory trends, and share relevant information within Promotional Regulatory Affairs and the business, as appropriate.

Desired Qualifications

  • Experience with electronic review and approval programs such as Veeva PromoMats or similar programs.
  • Experience influencing others' decision-making.
  • Experience in therapeutic areas of AstraZeneca focus.
  • Pharmaceutical or biotechnology regulatory, compliance, commercial, or medical affairs experience.
  • Experience working in a team-based environment.
  • A collaborative and solution-oriented mindset.
  • Effective verbal and written communication and influencing skills.
  • Strong compliance ethics and high concern for standards.
  • Strategic and analytical thinking and decision-making skills.
  • Ability to manage a diverse workload and quickly adjust to changing business priorities.
  • Ability to manage, coordinate, and execute projects independently with minimal supervision and in a timely manner.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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