Regulatory Affairs Director
hace 6 días
**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**.
This role, as a Regulatory Affairs Director (RAD), is responsible for providing strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s). The RAD applies knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies and influences regulatory authorities through regular contacts to improve regulatory outcomes.
**What you’ll do **
- Develop and implement the regional or global regulatory strategy, ensuring it is crafted to deliver rapid approval with competitive labelling that is identified by the business, markets and patients
- Lead the development of the global regulatory strategy document for assigned product(s) and the planning and construction of the global dossier and core prescribing information
- Lead cross functional teams in major regulatory submissions (BLA/MAA/IND/CTA), health authority interactions, label discussions, and securing approvals
- Deliver regulatory milestones for assigned project(s), including the assessment of risks and mitigations, emerging data and the probability of regulatory success
- Ensure effective collaboration across global, regional and local Regulatory Affairs, enabling rapid and effective submissions, approvals and other product maintenance activities
- Participate in skill-development, coaching and performance feedback of other regulatory staff working on the product/project
**Your Education, Qualifications, Skills and Experience**
**Essential**
- Bachelor’s Degree in a life science or related field
- Significant experience in early and late-stage regulatory drug development, manufacture, commercialization or equivalent
- Knowledge of regulatory procedures and legislation for drug development, product registration, line extensions and license maintenance
- Proven successful leadership and project management experience
**Desirable**
- Previous experience in vaccines or immune therapies is strongly preferred
- Advanced degree in science related field and/or other appropriate knowledge/experience
- Ability to work strategically within a business-critical and high-profile development program
- Critical thinking on current global regulatory science questions and a good understanding of the corresponding scientific and clinical components
**Locations**:
Cambridge, & Macclesfield in the UK; Gothenburg and Gärtuna (Sodertalje) in Sweden; Gaithersburg Maryland, Durham, North Carolina, Waltham and Wilmington in the US and Mississauga in Canada
Rewards:
Competitive salary and excellent benefits, some relocation support available
**Next Steps**:
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