Associate Director – Regulatory Affairs – Vaccines & Immunology

Our aim is to work towards a cure for some of the world’s most complex diseases.

AstraZeneca’s pipeline of innovative medicines is consistently growing within Respiratory and Immunology (R&I) and Vaccine and Immune Therapies (V&I). To meet the growing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of Associate Regulatory Affairs Directors (ARADs).

You will work across multiple therapy areas in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered and equal partner in the business.

Associate Regulatory Affairs Director is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to Global Regulatory Execution team (GRET), Global Regulatory Strategy team (GRST) and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives to support our growing portfolio.

Accountabilities/Responsibilities:

  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
  • Submission delivery strategy of all dossiers and all application types per market and /or region
  • Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
  • Analysis of regulatory procedures and special designations used during development, authorisations and extension of the product.
  • Use and share standard methodologies, when handling various applications and procedures during interactions with Health Authorities and in day-to-day work, while operating in a highly dynamic environment.
  • Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
  • Lead GRST & GRET sub-teams, i.e. Cross functional Submission Delivery teams for major submissions (NDA/MAA or major Lifecyle Management (LCM) initiative).
  • Develop, implement and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated partners.
  • Coordinate the input, maintenance and revision in the PLANIT project plans for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Lead Regulatory Project Manager (RPM) and line manager.
  • Identify regulatory risks and communicate mitigations to Lead RPM and cross functional teams.
  • Support operational and compliance activities for assigned results
  • May assume assigned responsibilities for routine and non-routine contact with Health Authorities and marketing companies.
  • Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Manager (RAM) skill group.
  • Contribute to process improvement.

Minimum Requirements

  • Relevant University Degree in Science or related subject area
  • Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
  • Thorough knowledge of drug development
  • Strong project management skills
  • Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

  • Managed first wave Marketing Application and/or LCM submissions
  • Managed complex regulatory deliverables across projects/products
  • Knowledge of AstraZeneca business and processes

Salary: Competitive

Advertising opens on 15th February 2022 and we welcome with your application; CV and cover letter, no later than 1st March 2022

For more information please contact: ruth.bannister@astrazeneca.com

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