Regulatory Affairs Senior Manager

Overview

In this role you will lead EMA regulatory affairs for Europe, shaping regulatory strategy and submissions for a portfolio of products. You will act as the primary regulatory advisor to R&D, clinical, quality and commercial teams, ensuring alignment with EU requirements. You’ll monitor evolving regulations and contribute to audits and regulatory intelligence to support compliant product lifecycle management. This position combines strategic oversight with hands-on submission leadership in a fast-paced, quality-driven environment.

Responsibilities

• Develop and execute regulatory strategies for Europe aligned with EMA requirements
• Lead and manage EMA submissions (MAA, variations, line extensions, renewals)
• Serve as primary liaison with EMA, competent authorities and regulatory bodies
• Provide regulatory guidance to cross-functional teams (R&D, clinical, quality, commercial)
• Evaluate new regulations, guidance, and industry trends to ensure ongoing compliance
• Contribute to internal audits, inspections, and regulatory intelligence initiatives

Key requirements

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline
• Strong regulatory affairs experience with a focus on EMA submissions
• Proven experience preparing and submitting MAA, CTD dossiers, variations, and renewals
• Solid understanding of EU pharmaceutical regulations and guidelines
• Excellent written and verbal communication skills
• Demonstrated ability to lead projects and influence cross-functional teams

• strong communication
• leadership
• cross-functional collaboration
• EMA submissions
• MAA
• CTD dossiers

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