Senior Regulatory Affairs & Labeling Manager

Michael Page; Lisboa; On-site; EUR 90,000 - 130,000; Full time

Job summary

Michael Page client in Lisbon is seeking a senior Regulatory Labelling Lead to oversee European labelling activities for generic and branded products. You will ensure regulatory compliance, drive operational excellence, and implement timely labelling updates across the product lifecycle.

You will coach a high-performing labelling team, provide strategic guidance on EU requirements (SmPC, PIL, CCDS), and partner with Regulatory Affairs, Quality, Supply Chain and Legal to deliver end-to-end

Qualifications

• Minimum 5 years in product labelling or regulatory affairs in pharma/healthcare.
• Proven leadership of cross-functional teams in matrix organisations.
• Deep knowledge of EU labelling regulations (SmPC, PIL, CCDS) and product lifecycle.
• Strong stakeholder management and project leadership skills.
• Experience with Lorenz and TrackWise and document management platforms is advantageous.

Responsibilities

• Lead regional labelling activities across Europe for generic and branded products.
• Ensure regulatory compliance and timely implementation of labelling updates.
• Coach and develop a high-performing labelling team with clear objectives.
• Provide strategic regulatory leadership on EU requirements and CCDS assessments.
• Collaborate with Regulatory Affairs, Medical Affairs, Quality, Supply Chain, Launch Management and Legal.
• Drive continuous improvement and support audits and inspections.

Skills

Regulatory leadership

Labelling regulations

Stakeholder management

Project leadership

Team development

Education

Degree in Life Sciences or related

Tools

Lorenz

TrackWise

Job description

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.