Regulatory Affairs Manager

Diverse Minds. Go further with bold new opportunities Collaborate with diverse minds

Collaborate in an inclusive environment, a place full of bold new opportunities. And in return… we’re looking for people who are open and respectful, ambitious and driven.

Who we are

Naturally curious, we are forever connecting and collaborating. Uncovering new insights that equip us to challenge convention and push the boundaries.

How we do it

Committed to living our values – they guide our behaviours, actions and decisions, everyday.

It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.

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.

As a Regulatory Affairs Manager in Cambridge, you’ll work within AZ’s Biopharmaceuticals R&D Late Cardiovascular, Renal and Metabolism (CVRM) team, a patient-centric organization collaborating to deliver valuable medicines that address unmet patient needs in cardiovascular, renal and metabolism-driven disease .

The Late CVRM team accomplish this within an agile, talented and highly motivated team that sustainably follows the science, data and technology to accomplish our goal of ultimately achieving disease control and clinical remission in these disease areas.

Within the Late CVRM Regulatory Affairs Team you will support the development and execution of regulatory strategies for global programs across the entire lifecycle by proactively leveraging and applying the broad regulatory and scientific expertise, leadership skill and business acumen to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit patients.

Main Duties and Responsibilities

The Regulatory Affairs Manager (RAM), in Late CVRM Regulatory Affairs is a regulatory specialist with 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, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

In this role you will be responsible for understanding 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.), and analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

You will use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. In addition, you will be leading 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 will develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. You will coordinate the input, maintenance and revision in the project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager. You will Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams. You will also support operational and compliance activities for assigned deliverables, 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. You will provide coaching, mentoring and knowledge sharing within the RAM skill group, and contribute to process improvement.

Essential Requirements

  • B.A. or B.S. Degree in Science or related discipline
  • 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
  • Excellent written and verbal communication skills
  • Cultural awareness
  • Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
  • Proficiency with common project management (e.g., MS Project) and document management tools
  • Ability to work independently and as part of a team
  • Influencing and stakeholder management skills
  • Ability to analyze problems and recommend actions
  • Continuous Improvement and knowledge sharing focused

Desirable Requirements

  • Regulatory experience
  • Managed regulatory deliverables at the project level
  • Thorough knowledge of the drug development process
  • Knowledge of AZ Business and processes
  • Regulatory experience

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 26th August 2021 and we welcome with your application; CV and cover letter, no later than 9th September 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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