AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Associate Regulatory Project Director
Competitive Salary and Benefits
AstraZeneca is at a critical phase in the journey to deliver our bold ambition; to improve the lives of 200 million patients and be a $50 billion company in 2025. We are on track to deliver 10 new medicines by 2020, and we have one of the most exciting portfolios in the industry.
The Regulatory Project Management group sits within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organisation and 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 an experienced Associate Regulatory Project Director (ARPD) to join our UK Oncology team. The 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 Startegy team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Responsibilities as the ARPD:
You 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 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.
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.
You will 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.
You will lead GRST & GRET sub-teams, i.e. Cross-functional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative).
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 OPAL 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 communicate mitigations to Lead RPM and cross functional teams.
You will support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, Trial Master File, and document management utilizing the support and input of Global Regulatory Operations, Marketing Companies, Clinical Research Organistions and/or alliance partners where relevant.
You might also assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
You will provide coaching, mentoring and knowledge sharing within the RPM skill group.
Minimum Requirements –Education and Experience
- Relevant University 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
- Experience of working in the Oncology regulatory environment in both Small and Large molecules
- Managed first wave Marketing Application and/or LCM submissions in particular European centralized procedure
- Managed complex regulatory deliverables across projects/products
- Global regulatory experience
Skills and Capabilities
- 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
If you are interested please apply by submitting your CV before 23rd 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.