Regulatory Project Manager - Oncology (12 month contract)
- Experience Level
- Experienced (non-manager)
Would you like to use your regulatory project management experience to help deliver life changing medicines to patients? If you would please read on!
At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover.
Within Oncology Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it - working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we're growing fast and we're as focused and committed to the development of our people as we are our business - providing an open and supportive space to explore, learn, grow and develop across all roles and levels.
Regulatory Project Managers (RPMs) are Regulatory Affairs specialists with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM 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 RPM 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.
We currently have an exciting opportunity for an RPM on a 12 month contract/secondment to join the Oncology Regulatory Project Management team.
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, execute 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 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 RPM 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
- Regulatory experience
- Managed regulatory deliverables at the project level
- Detailed knowledge of the drug development process
Location: Cambridge, UK
Salary: Competitive + Excellent Benefits
Closing Date: 6th July 2021
Next steps, If you feel you are suitable for the role please apply!
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