Senior Regulatory Affairs Director
hace 3 semanas
**_Are you a strategically focused Regulatory Affairs professional and would like to play an integral part in shaping drug development and gaining fast, efficient regulatory approvals? If so, read on..._**
At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover. The **Vaccines and Immune Therapies (V&I) **group at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilizing our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious disease. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules and novel biologics platforms. Within V&I Regulatory Science and Strategy, we take innovative regulatory approaches and work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The **Senior Regulatory Affairs Director (SRAD) **is accountable for the development and implementation of the global regulatory strategy for a product/group of products within the V&I portfolio. The SRAD must possess strategic leadership skills and have a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs. You will provide team leadership and participate in coaching and mentorship to members of the Global Regulatory Strategy Team. You will be viewed as a senior leader within the regulatory community.
**What you’ll do**:
- Accountable for the development and implementation of innovative global strategies of increasing complexity, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients
- Accountable for product maintenance, supply and compliance activities associated with marketed brands
- Deliver all regulatory milestones, including the assessment of the probability of regulatory success, with risk analysis and mitigation
- Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities
- Lead the development of the global regulatory strategy document for assigned products/projects and the planning and construction of the global dossier and core prescribing information
- Provide regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal
- Participate in and promote novel regulatory initiatives internally and engage externally on corresponding topics as needed
**Essential requirements**:
- Bachelor’s degree in a life science or related discipline
- Substantial direct experience of working as the interface with regulatory authorities and leading delivery of regulatory projects through key milestones and investment decisions
- Broad background of experience working in several areas within regulatory affairs or therapy areas, including early and late-stage development
- Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment
**Desirable **requirements**:
- Previous experience in vaccines or immune therapies is strongly preferred
- Advanced degree in science related field and/or other appropriate knowledge/experience
- Previous experience with major regulatory authority meetings in multiple regions
- Previous experience working on due diligence activities and in a business alliance environment
**Locations**: Macclesfield, UK; Gothenburg and Södertälje, Sweden and Barcelona, Spain.
**So, what’s next?**
**Why AstraZeneca?**:
AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. There’s no better place to see what science can do.
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