Regulatory Affairs Manager
- Compensation
- Not disclosed
- Location
- London, England, United Kingdom
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Full time
- Experience
- 4+ years
- Category
- Legal
- Posted
Skills
Nice to have
- Experience with clinical trial applications and trial maintenance activities, including the use of in-vitro diagnostics (IVDs) in the clinical trial setting.
- Experience using AI solutions to simplify and improve departmental processes/ways of working.
- Experience in creating and delivering regulatory strategies for marketing authorisation applications and new indications.
- Experience working in Veeva systems.
- Management of reactions to change while remaining effective in new work situations and times of uncertainty; assessment, planning and management of the impact of changes on stakeholders; and applicati
- A robust understanding of a relevant disease and therapeutic area, including the regulatory and health technology assessment environment in the major markets, the competitor landscape, and predictable
Full description
Type: PermanentLocation: Pancras SquareIntroduction to the role
Deliver 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 the provision of local regulatory expertise. Support the development of AstraZeneca investigational and in-licensed/co-development products through valued contributions to cross-functional projects, study feasibility questionnaires, scientific advice meetings, and other related activities. Ensure full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AstraZeneca policies and standards.
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 working within a regulatory affairs organisation in a UK-based or global pharmaceutical company.
- Post-Brexit UK regulatory experience.
- Business relationship management skills and the ability to navigate and coordinate cross-functional interactions..
- Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
- Demonstrable negotiation skills.
- Ability to make optimal use of IT systems.
- Knowledge of the external regulatory environment and regulatory science expertise support building a productive, positive and trustworthy relationship with the UK MHRA to drive meaningful interactions to the benefit of patients.
- Lifecycle maintenance of UK Regulatory licenses, including different types of submissions, including but not limited to CMC, Labelling, etc.
- Optimisation and continuous improvement of submissions throughout the product lifecycle, applying global quality standards and timelines.
- Development of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategies.
- Application of knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunities.
- Application of drug development knowledge.
- Audit and inspection knowledge.
Desirable Skills/Experience
- Experience with clinical trial applications and trial maintenance activities, including the use of in-vitro diagnostics (IVDs) in the clinical trial setting.