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AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Regulatory Affairs Director

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

About the Job

Requirements

  • Bachelor’s degree in Life Science or a related discipline.
  • Six years of experience in regulatory drug development, manufacture, commercialization, or equivalent.
  • Proven successful leadership and project management experience.
  • Broad experience working in several groups in regulatory affairs or experience at a health authority.
  • Knowledge of regulatory procedures and legislation for drug development, product registration, line extension, and licence maintenance.

Responsibilities

  • Provide strategic and operational regulatory leadership to the development, commercialization, and life cycle management of assigned products in product teams.
  • Apply knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies.
  • Influence regulatory authorities through regular contacts to improve regulatory outcomes.
  • Provide lobbying and influencing support to regulatory agencies and trade associations on product and legislative development issues, and monitor changes in the regulatory environment in the nominated region.
  • Provide strategic regulatory advice and support for product developments in the regional therapy area.
  • Represent AZRA on relevant external trade association committees to communicate AZRA and/or AZ views on key issues.
  • Ensure adequate risk assessments and mitigation plans are included in regulatory strategy documents.
  • Contribute effectively to global development programmes by providing expert advice and interpretive input on market legislation and requirements affecting new and existing product registrations.
  • Ensure effective collaboration across global, regional, and local Regulatory Affairs interfaces to enable rapid and effective submissions, approvals, and product maintenance activities.
  • Participate in skill development, coaching, and performance feedback for other regulatory staff working on the product or project.
  • Ensure all markets remain compliant with maintained product licences and that improvement plans are in place to close compliance gaps.
  • Provide support and advice on training and development so regulatory personnel in markets have appropriate knowledge of quality and compliance.
  • Create a culture of courageous leadership, creativity, and collaboration.

Desired Qualifications

  • Advanced degree such as an MS, PharmD, or PhD.

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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