Sr. Manager, Regulatory Affairs

Responsibilities

Our talent team is representing a confidential biopharmaceutical organization seeking a Sr. Manager, Regulatory Affairs based in Maidenhead. In this role, you will collaborate with regulatory leads and cross-functional teams to facilitate submissions to EU and international health agencies for innovative therapeutics.

Your key responsibilities will include:

• Leading the planning, preparation, and delivery of regulatory submissions throughout the product lifecycle, including Clinical Trial Applications (CTAs), responses to health authority questions, substantial modifications, notifications, meeting requests, and briefing documents
• Supporting preparation of Paediatric Plans, Orphan Designation applications, expedited pathway applications, and Marketing Applications with amendments
• Developing detailed regulatory project plans and supporting regulatory activities for assigned products and projects
• Serving as the regulatory representative on multidisciplinary product development teams and providing EU regulatory guidance
• Coordinating responses to regulatory authority questions with strict adherence to deadlines
• Acting as liaison between internal departments, contract research organizations, and regulatory program managers at health agencies
• Maintaining regulatory files consistent with internal requirements and facilitating review of technical regulatory documentation
• Providing EU-specific regulatory intelligence to internal stakeholders

What We're Looking For

• Bachelor's degree with 4+ years of experience in a Regulatory Affairs strategy role within biotech or pharmaceutical industry; advanced scientific degree preferred
• Solid understanding of EU regulations and experience interpreting regulatory guidelines
• Experience with regulatory filings and electronic submissions, including CTAs, DSURs, post-marketing variations, and paediatric plans
• Excellent written and verbal communication skills, including negotiation and influencing abilities
• Strategic thinking capability with ability to proactively identify issues and mitigation strategies in drug development
• Excellent organizational and project management skills with demonstrated ability to prioritize multiple projects simultaneously
• Strong interpersonal skills to work effectively in team environments across departments and with external partners
• Technical proficiency with word processing, spreadsheets, databases, and submission-ready formatting

How We Work with You

Candidates apply directly through Get A Job.ai. Our recruiters will conduct an initial screening to understand your background and qualifications. Once we confirm alignment, we submit your profile to our client for consideration. Please do not attempt to contact the client directly, as all communication is managed through our talent team to ensure a smooth process for everyone involved.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive recruitment practices and equal employment opportunity. We welcome candidates from all backgrounds and experiences.