Senior Manager Regulatory Affairs

Park Street People; Greater London; On-site; GBP 90,000 - 120,000; Full time

Job summary

Park Street People is seeking a Senior Regulatory Manager to drive EMA regulatory affairs across Europe. You will lead regulatory strategy, manage submissions, and act as the regulatory advisor for our product portfolio while collaborating with R&D, quality, clinical, and commercial teams.

The role requires deep knowledge of EMA guidelines, CTD/MAA submissions, and a proven ability to influence cross-functional teams to ensure compliant, timely market access.

Qualifications

• 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.

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.

Skills

Regulatory affairs

EMA submissions

Cross-functional leadership

Project leadership

Written and verbal communication

Education

Bachelor’s or Master’s degree in Pharmacy/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.