EMA Regulatory Lead – Remote Europe

Y-Axis; Greater London; Hybrid; GBP 85,000 - 110,000; Full time

Job summary

Park Street People Ltd. is recruiting a Senior Regulatory Manager for a pharmaceutical client. The role focuses on EMA regulatory affairs, leading strategy, and managing submissions across Europe.

You will liaise with EMA and authorities, guiding cross-functional teams to ensure compliance and timely market access. The ideal candidate has a strong background in EMA submissions and EU regulations, with proven leadership in regulatory projects and a track record of successful MAA submissions and

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
• Strong EMA regulatory affairs experience with a focus on submissions.
• Experience preparing MAA, CTD dossiers, variations and renewals.
• Knowledge of EU pharmaceutical regulations and guidelines.

Responsibilities

• Develop and execute regulatory strategies for Europe in line with EMA requirements.
• Lead EMA submissions, including MAA, variations, line extensions, and renewals.
• Act as primary liaison with EMA and competent authorities.
• Provide regulatory guidance to R&D, clinical, quality, and commercial teams.
• Monitor new regulations and industry trends to ensure compliance.
• Contribute to regulatory inspections and intelligence activities.

Skills

Regulatory affairs

EMA submissions

Cross-functional liaison

Quality compliance

Education

Pharmacy/Life Sciences degree

Job description

Park Street People Ltd. is recruiting a Senior Regulatory Manager for a pharmaceutical client. The role focuses on EMA regulatory affairs, leading strategy, and managing submissions across Europe.

You will liaise with EMA and authorities, guiding cross-functional teams to ensure compliance and timely market access. The ideal candidate has a strong background in EMA submissions and EU regulations, with proven leadership in regulatory projects and a track record of successful MAA submissions and