Regulatory Affairs Manager

About the Role

Our client is seeking a seasoned Regulatory Affairs Manager to lead their regulatory strategy and submissions in Leeds . This hybrid role requires a strategic thinker with a deep understanding of the pharmaceutical regulatory landscape. You will be responsible for ensuring compliance with all relevant health authority regulations, managing the preparation and submission of regulatory dossiers, and liaising with regulatory agencies worldwide. This is an excellent opportunity to shape the regulatory pathway for innovative medicines and contribute to patient access, working within a supportive team that values expert knowledge and strategic guidance.

Key Responsibilities

• Develop and implement global regulatory strategies for product development and registration.
• Oversee the preparation, review, and submission of marketing authorization applications (MAAs) and other regulatory filings.
• Serve as the primary point of contact for health authorities, managing communications and responding to queries.
• Ensure compliance with all applicable regulations and guidelines across different markets.
• Lead and mentor a team of regulatory affairs professionals.

Requirements

• Master's degree or PhD in a scientific or related field.
• Significant experience (7+ years) in pharmaceutical regulatory affairs .
• Proven track record of successful regulatory submissions and approvals in key markets.
• In-depth knowledge of international regulatory guidelines (e.g., FDA, EMA, ICH).
• Strong leadership, negotiation, and project management skills for a hybrid work environment .

Benefits

• Executive-level salary and bonus structure.
• Private healthcare and life insurance.
• Generous company pension scheme.
• Professional development and conference attendance allowance.
• Flexible working policy balancing office and remote work.