Senior Regulatory Affairs Manager

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

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