Regulatory Affairs Senior Manager

The Role:

We are seeking an experienced Senior Regulatory Manager with strong expertise in EMA regulatory affairs to join their dynamic team. This role offers the opportunity to lead regulatory strategy, manage submissions, and act as a key regulatory advisor for our product portfolio across the European region.

Key Responsibilities:

• Develop and execute regulatory strategies for products under development and marketed products in Europe, ensuring alignment with EMA requirements.
• Lead and manage EMA submissions, including MAA, variations, line extensions, and renewals.
• Act as primary liaison with EMA, competent authorities, and other regulatory bodies.
• Provide regulatory guidance to cross-functional teams (R&D, clinical, quality, commercial) throughout the product lifecycle.
• Evaluate and interpret new regulations, guidance, and industry trends to ensure ongoing compliance.
• Contribute to internal audits, inspections, and regulatory intelligence initiatives.

Qualifications & Experience:

• 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 in preparing and submitting MAA, CTD dossiers, variations, and renewals.
• Strong understanding of EU pharmaceutical regulations and guidelines.
• Excellent written and verbal communication skills.
• Demonstrated ability to lead projects and influence cross-functional teams.