Regulatory Affairs Manager

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What we do

Ultimately, our aim is to work towards a cure for some of the world’s most complex diseases. Whether that’s by shaping the patient ecosystem and focusing on outcomes, or by progressing potential medicines and accelerating their launch.

How we do it

The shared creativity through both internal and external collaboration unlocks challenges and brings new solutions.

Why we love it

This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

The role

AstraZeneca’s pipeline of innovative medicines is consistently growing within Respiratory and Immunology (R&I) and Vaccines and Immune Therapies (V&I). To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Managers. With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and large molecules. You will work across multiple therapy areas in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

Regulatory Affairs Managers (RAMs) are Regulatory Affairs specialists with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, whilst leading simple through to more complex regulatory applications and managing procedures through to regulatory approval. The RAM 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, what you will be doing:

  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • You will provide regulatory input 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 of documents (e.g. response documents, study protocols, PSRs, etc.).
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • You’ll 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 simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
  • You’ll 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 RPM and line manager.
  • Identify regulatory risks and propose mitigations to Lead Regulatory Project Manager and cross functional teams.
  • Support operational and compliance activities for assigned results, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
  • Provide coaching, mentoring and knowledge sharing within the RAM skill group.
  • Contribute to process improvement.

Minimum Requirements – Education and Experience:

  • Relevant University Degree in Science or related field
  • Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
  • General knowledge of drug development
  • Strong project management skills
  • Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience:

  • Regulatory experience
  • Managed regulatory results at the project level
  • Detailed knowledge of the drug development process

Next steps, If you feel you are suitable for the role please apply!

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on 21st December 2021 and we welcome with your application; CV and cover letter, no later than 10th January 2021

For more information please contact: alexander.doyle@astrazeneca.com

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources

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