AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Regulatory Project Manager
Location: Granta Park, Cambridge
Competitive Salary & Benefits
We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has a big impact on science and medicine.
The Regulatory Project Management group is accountable for end to end regulatory project delivery, providing regulatory expertise, efficient project management and strong leadership in line with business priorities.
We are now looking to recruit Regulatory Project Managers within our UK Oncology team. These roles will be based in Cambridge. The Regulatory Project Manager (RPM) is a regulatory specialist with 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 approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy Team), and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
As a RPM responsibilities will include:
Monitoring and interpreting the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
Providing regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
Using and sharing best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work.
Leading and / or contributing to the planning, preparation 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.
Developing, executing and maintaining submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
Coordinating the input, maintenance and revision to the project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
Identifying regulatory risks and propose mitigations to Lead RPM and cross functional teams.
Supporting operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, Trial Master File (TMF), and document management utilizing the support and input of Global Regulatory Operations, Marketing Companies, Contract Resource Organisations and/or alliance partners where relevant.
Providing coaching and knowledge sharing within the RPM skill group as appropriate.
Contributing to process improvement.
- Relevant University Degree in Science or related discipline
- Some Regulatory experience
- General knowledge of the drug development process
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Excellent written and verbal communication skills
- Influencing and stakeholder management skills
- Continuous Improvement and knowledge sharing focused
Should you be interested in this role, please apply by submitting your CV before 24th May 2019.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.