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AstraZeneca

Global pharmaceutical company developing prescription medicines

Associate Director - Promotional Regulatory Affairs

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in pharmacy, pharmacology, life science, or a related field, or equivalent experience, is a plus.
  • Five years of experience in drug or biologic regulatory affairs or a related pharmaceutical or biotech field.
  • Working knowledge of FDA promotional regulations and the ability to apply that knowledge when reviewing diverse promotional materials and audiences.
  • Working knowledge of the drug development process.
  • Experience with electronic review and approval programs such as VEEVA PromoMats or another program is a plus.

Responsibilities

  • Provide regulatory guidance and risk assessment to cross-functional review teams and business teams so initiatives comply with applicable U.S. laws, rules, and regulations governing pharmaceutical advertising and promotion.
  • Lead review and adjudication of promotional materials 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, including current interpretations and recommendations related to FDA promotional regulations and associated guidance.
  • Conduct regulatory review and risk assessment of promotional materials for healthcare professionals, consumers, and managed markets across print, broadcast, and electronic media; sales and faculty training; Proactive Scientific Exchange by SciP; Corporate Affairs communications; and other materials reviewed through AZAP.
  • Conduct reviews within established timelines and address 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 consultative meetings, as requested.
  • Provide business guidance to support implementation of brand strategies, as requested.
  • Develop promotional regulatory guidance and job aids for department and cross-functional partner 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 with the Internal and/or External Training Initiative or Promotional Regulatory Affairs Skill Center.
  • Monitor regulatory agency activities, new guidance, and emerging trends in the regulatory environment, and share relevant information within Promotional Regulatory Affairs and the business.

Desired Qualifications

  • Experience influencing others' decision-making.
  • Experience in therapeutic areas that are areas of AstraZeneca focus.
  • Pharmaceutical or biotech regulatory, compliance, commercial, or medical affairs experience.
  • Experience working in a team-based environment.
  • A collaborative and solution-oriented approach.
  • 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 adjust quickly 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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