Overview
As Senior Manager, Regulatory Affairs you will shape and execute global regulatory strategy for a late-stage biotech program. You will work closely with senior stakeholders and external partners to navigate major markets, including FDA, EMA, MHRA, Health Canada and TGA. The role is hands-on, combining regulatory submissions, health authority interactions and strategic planning to accelerate development timelines. You will lead cross-functional collaboration, drive process improvements, and guide a regulatory team in a lean, fast-paced setting. This is an impactful opportunity to influence global development strategy and ensure inspection readiness.
Responsibilities
- Supporting global regulatory and development strategy
- Leading and supporting health authority interactions
- Preparing and reviewing briefing packages, submissions and agency responses
- Managing regulatory planning, commitments and key milestones
- Overseeing CROs, consultants and external regulatory service providers
- Supporting regulatory and inspection readiness
- Developing and improving regulatory processes, SOPs and governance
- Providing regulatory input into cross-functional development plans and key programme decisions
- Supporting and managing members of the Regulatory Affairs team
Key requirements
- Significant Regulatory Affairs experience within pharma or biotech
- Strong experience supporting clinical-stage and late-phase development programmes
- Hands-on experience with regulatory submissions and health authority interactions
- Experience working with FDA, EMA, MHRA or other major international agencies
- Strong regulatory operations and project management capability
- Experience working within an outsourced or virtual biotech model
- CRO and external vendor management experience
- Strong cross-functional stakeholder management
- A pragmatic, commercially aware and hands-on approach
- Experience operating within a lean, fast-paced biotechnology environment
- cross-functional collaboration
- stakeholder management
- problem-solving
- regulatory submissions
- health authority interactions
- regulatory operations
Senior Regulatory Affairs Manager in London employer: Barrington James
Barrington James is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals in Epidemiology and Real-World Evidence. With a strong emphasis on employee growth, we offer tailored development opportunities and the chance to lead impactful projects across diverse therapeutic areas in the dynamic UK/Europe market. Join us to be part of a team that values flexibility, creativity, and meaningful contributions to healthcare advancements.
