Global Regulatory Affairs Project Lead

Hyper Recruitment Solutions Ltd; Noord-Brabant; On-site; EUR 70,000 - 100,000; Full time

Job summary

Hyper Recruitment Solutions Ltd seeks a Regulatory Affairs Project Manager to lead regulatory projects across the product lifecycle, coordinating with Regulatory Affairs, CMC, Quality, Clinical and Pharmacovigilance teams to ensure compliant submissions on time.

The role requires a life sciences degree and proven project management experience in regulated environments, with strong stakeholder management and clear communication to coordinate cross-functional teams and external partners.

Qualifications

• Proven project management experience within pharmaceutical, biotechnology, life sciences or a related regulated environment.
• Knowledge of Regulatory Affairs, CMC, regulatory strategies, submission pathways and lifecycle activities.
• Degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology or related life sciences.
• Excellent communication and stakeholder management skills; ability to coordinate cross-functional teams.

Responsibilities

• Lead and manage multiple regulatory projects, ensuring delivery against timelines, budgets and quality expectations.
• Develop and maintain project plans, risk registers and resource allocations, identifying risks and mitigation strategies.
• Coordinate cross-functional teams and facilitate project governance meetings, providing progress updates to stakeholders.
• Support global regulatory activities including new product development, agency interactions, renewals, variations, lifecycle management and CTD oversight.
• Act as primary contact for assigned clients and stakeholders, contributing to continuous improvement of regulatory project management processes.

Skills

Project management

Stakeholder management

Communication

Organisational skills

Education

Life sciences degree (Pharmacy/Pharmaceuticals/Chemistry/Biotech)

Job description

Hyper Recruitment Solutions Ltd seeks a Regulatory Affairs Project Manager to lead regulatory projects across the product lifecycle, coordinating with Regulatory Affairs, CMC, Quality, Clinical and Pharmacovigilance teams to ensure compliant submissions on time.

The role requires a life sciences degree and proven project management experience in regulated environments, with strong stakeholder management and clear communication to coordinate cross-functional teams and external partners.