Senior Regulatory Affairs & Labeling Manager

Michael Page; Viseu; Sur place; EUR 85 000 - 120 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Leadership

Regulatory affairs

Stakeholder management

Cross-functional collaboration

Formation

Degree in Life Sciences

Pharmacy

Biotechnology

Outils

Lorenz

TrackWise

Description du poste

Lead European labelling activities, ensuring regulatory compliance and timely delivery of product labelling updates while driving operational excellence. Client Details

Our client is a global healthcare company committed to improving access to high-quality medicines and healthcare solutions worldwide. Focused on improving patients' lives, the company delivers essential treatments and supports healthcare needs across all stages of life. Description

Lead and oversee regional labelling activities across Europe for both generic and branded products, ensuring regulatory compliance, operational excellence and the timely implementation of labelling updates throughout the product lifecycle. Manage, coach and develop a high-performing labelling team, setting clear objectives and fostering a collaborative environment focused on quality, accountability and continuous improvement.

Provide strategic regulatory leadership and expert guidance on EU labelling requirements, including the interpretation of regulations, CCDS assessments, health authority interactions and the development of labelling strategies for new and marketed products. Partner closely with Regulatory Affairs, Medical Affairs, Quality, Supply Chain, Launch Management and Legal teams to ensure seamless end-to-end execution from regulatory approval through artwork implementation and market release.

Drive continuous improvement initiatives, maintain awareness of emerging regulatory requirements, support audits and inspections, and ensure adherence to company procedures, governance standards and best practices. Profile

Degree in Life Sciences, Pharmacy, Biotechnology or a related scientific discipline, combined with a minimum of 5 years' experience in product labelling and regulatory affairs within the pharmaceutical, biotechnology or healthcare sector. Proven leadership experience in managing and developing high-performing teams, as well as leading cross-functional initiatives within complex, matrix-driven organisations.

Strong expertise in global and European labelling regulations and processes, including SmPC, PIL and CCDS, with the ability to develop compliant and effective labelling strategies. Excellent stakeholder management, communication and project leadership skills, with a demonstrated ability to influence across functions and drive complex projects to successful completion. Experience with electronic submission and change control systems, such as Lorenz and TrackWise®, as well as document management platforms, would be considered advantageous. Job Offer

The company offers a competitive compensation and benefits package, as well as the opportunity to work in a collaborative, international, and cross-functional environment that values diversity, inclusion, and professional growth.