Senior EU Regulatory Labeling Lead | Strategy & Compliance

Michael Page; Viseu; On-site; EUR 85,000 - 120,000; Full time

Job summary

Michael Page is seeking a Senior Regulatory Labelling Lead for a global healthcare client operating across Europe. You will oversee regional labelling activities, ensure regulatory compliance, and drive timely updates throughout the product lifecycle.

You will build and coach a high-performing team, partner with Regulatory Affairs, Medical Affairs, Quality, and Supply Chain, and develop EU labelling strategies for SmPC, PIL and CCDS while guiding audits and change-control processes.

Qualifications

• Minimum 5 years' experience in product labelling and regulatory affairs.
• Proven leadership of high-performing cross-functional teams.
• Strong knowledge of EU labelling regulations and processes (SmPC, PIL, CCDS).

Responsibilities

• Lead regional labelling activities across Europe for both generic and branded products.
• Coordinate with Regulatory Affairs, Medical Affairs, Quality, Supply Chain, Launch Management and Legal teams.
• Drive continuous improvement initiatives and ensure adherence to procedures and governance standards.

Skills

Leadership

Regulatory affairs

Stakeholder management

Cross-functional collaboration

Education

Degree in Life Sciences

Pharmacy

Biotechnology

Tools

Lorenz

TrackWise

Job description

Michael Page is seeking a Senior Regulatory Labelling Lead for a global healthcare client operating across Europe. You will oversee regional labelling activities, ensure regulatory compliance, and drive timely updates throughout the product lifecycle.

You will build and coach a high-performing team, partner with Regulatory Affairs, Medical Affairs, Quality, and Supply Chain, and develop EU labelling strategies for SmPC, PIL and CCDS while guiding audits and change-control processes.