Senior Manager Regulatory Affairs

Park Street People; Slough; On-site; GBP 80,000 - 110,000; Full time

Job summary

Park Street People Ltd is recruiting a Senior Regulatory Manager for a pharmaceutical company in Europe. The role focuses on leading EMA regulatory affairs strategy, submissions, and regulatory advisory across the European portfolio.

The ideal candidate has strong EMA experience, proven ability to lead cross-functional teams, and excellent communication skills to influence stakeholders across R&D, QA, clinical, and commercial groups.

Qualifications

• Experience in EMA submissions and CTD dossiers.
• Ability to lead cross-functional teams across R&D, QA, clinical and regulatory.
• Excellent written and spoken communication skills.

Responsibilities

• Develop and execute regulatory strategies for Europe in line with EMA requirements.
• Lead EMA submissions including MAA, variations, and renewals.
• Serve as the primary liaison with EMA and other authorities.
• Provide regulatory guidance throughout the product lifecycle to cross-functional teams.
• Monitor regulatory changes and advise on compliance and risk.

Skills

Regulatory affairs

EMA submissions

Cross-functional leadership

Regulatory strategy

Communication

Education

Bachelor’s/Master’s in Pharmacy or Life Sciences

Job description

We are supporting a pharmaceutical company committed to delivering innovative therapies that improve patients’ lives in recruiting a Senior Regulatory Manager. Their global teams collaborate to bring cutting-edge solutions from concept to market while maintaining the highest standards of quality and compliance.

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.

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.