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Introduction to roleDeliver and maintain competitive licences for the UK, driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities, including project leadership. Achieve timely delivery of clinical trial approvals and maintain high regulatory compliance standards for the UK through provision of local regulatory expertise. Support the development of AstraZeneca investigational and in-licensed/co-development products through contributions to cross-functional projects, study feasibility questionnaires, scientific advice meetings, and other activities. Ensure full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AstraZeneca policies and standards.
Type: Permanent
Location: Pancras Square
Accountabilities
- Generate Competitive Licences (0-40%)
- Regulatory Compliance & Governance (0-10%)
- Commercial Support (0-15%)
- Formulate and Influence Regulatory Strategy (0-15%)
- Lead the Organisation and Improve productivity (0-10%)
- Clinical Support (0-10%)
Essential Skills/Experience
- Life Sciences Degree or appropriate professional qualifications
- 4+ years experience in Regulatory Affairs within a UK-based or global pharmaceutical company
- Post-Brexit UK Regulatory experience
- Business Relationship Management and cross-functional coordination skills
- Operational regulatory experience in the pharmaceutical industry
- Regulatory Strategy Development
- Negotiation skills
- IT systems proficiency
- Knowledge of external regulatory environment and scientific expertise for effective interactions with health authorities
- Lifecycle management of licenses, including submissions like CMC, Labelling, etc.
- Continuous improvement of submission processes aligned with global standards
- Development of regulatory strategies aligned with disease area and product profiles
- Knowledge of changing regulatory environments to ensure compliance and minimize risks
Desirable Skills/Experience
- Therapy Area Expertise in Oncology, biologics, or medical devices
- Experience with regulatory strategies for orphan drugs or paediatric indications
- Change management skills
- Deep understanding of disease and therapeutic area, including regulatory and health technology assessment environments
At AstraZeneca, we change the practice of medicine by generating compelling medical evidence to help physicians better treat patients. Our teams work seamlessly to advance our pipeline and redefine cancer treatment. We foster a culture of openness, transparency, ambition, and drive. Here, you can grow your career while making a significant impact on patients’ lives.
Ready to make a difference? Apply now!
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