Associate Regulatory Project Directors-Oncology-12 m contract
- Experience Level
- Experienced (non-manager)
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.
As an Associate Regulatory Project Director in Cambridge, UK working within Oncology Regulatory Science and Strategy, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.
Roles are for an 12 month fixed-term contract or secondment.
The Associate Regulatory Project Director (ARPD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARPD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARPD 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.
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.
- Provide regulatory expertise 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 documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
- 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. You will also contribute to process improvement
- Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
- Lead GRST & GRET sub-teams, i.e. Cross functional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative).
- 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 communicate mitigations to Lead Regulatory Project Manager (LRPM) and cross functional teams.
- Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
- May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
- Provide coaching, mentoring and knowledge sharing within the RPM skill group. When assigned to a Lead RPM role an ARPD is responsible for leading the GRET with overall accountability for the project management of all GRET deliverables. They are also a key member of the Global Regulatory Strategy Team (GRST) with focus to deliver the GRST product plan submission milestones. This is achieved by development and execution of operationally efficient submission delivery plans by GRST and GRET members
Minimum Requirements - Education and Experience:
- BS/MS Degree in Science or related discipline
- Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
- Thorough Knowledge of drug development
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Managed first wave Marketing Application and/or LCM submissions
- Managed complex regulatory deliverables across projects/products
- Knowledge of AZ Business and processes
Location: Cambridge, UK
Closing Date: 24th January 2021
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.