Regulatory Affairs Manager

Introduction to role:

Are you ready to lead the charge in transforming breakthrough science into tangible value? As a Regulatory Affairs Manager, you'll be at the forefront of delivering life-changing treatments to patients worldwide. You'll manage the end-to-end planning, coordination, and execution of regulatory deliverables, contributing to submission strategies and identifying risks and opportunities. Your expertise will guide cross-functional teams, ensuring that our innovative solutions reach patients efficiently and effectively.

Accountabilities:
• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
  o Submission delivery strategy of all dossiers and all application types per market and/or region.
  o Review of documents (e.g. response documents, study protocols, PSRs, etc.).
  o Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product.
• 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.
• 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.
• Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• 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 RPM and cross-functional teams.
• 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.
• Provide coaching, mentoring, and knowledge sharing within the RAM skill group.
• Contribute to process improvement.

Essential Skills/Experience:
• Relevant University 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.

Desirable Skills/Experience:
• Regulatory experience.
• Managed regulatory deliverables at the project level.
• Thorough knowledge of the drug development process.
• Knowledge of AZ Business and processes.

At AstraZeneca, we are driven by science and success. Our inclusive environment fosters collaboration across global teams to unlock regulatory knowledge. We empower our employees to innovate fearlessly, taking smart risks to break barriers in drug development. With a rich pipeline and exposure to the complete drug delivery process, you'll have opportunities to grow and evolve in multiple roles. Join us in transforming meaningful innovation into life-altering solutions for patients.

Ready to make an impact? Apply now to become a part of our dynamic team!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.