Regulatory Affairs Manager Greece Cyprus Malta

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Job Description

About the Role

How You Will Contribute

• Lead regulatory lifecycle management activities, including new registrations, renewals, variations, PSUR/PBRERs, and national regulatory procedures.

• Manage national phases of European procedures and ensure timely regulatory submissions, approvals, and maintenance activities across Greece, Cyprus, and Malta.

• Assess the local impact of global dossier updates and coordinate implementation through established change control processes.

• Ensure product information, labelling, artworks, and mock-ups remain compliant with EU, local, and global regulatory requirements.

• Coordinate the preparation, review, approval, and distribution of local regulatory translations and affiliate feedback.

• Build and maintain effective relationships with local Health Authorities while serving as the primary regulatory liaison with Global Regulatory Affairs.

• Support regulatory compliance during audits and inspections while proactively identifying regulatory risks and process improvement opportunities.

• Provide regulatory expertise to cross-functional teams, including participation in MLR reviews and support for product launches and commercial initiatives.
  

What You Bring to Takeda

• Bachelor's degree in Life Sciences or another relevant scientific discipline.

• Minimum of 3 years' Regulatory Affairs experience, ideally within a multinational pharmaceutical environment.

• Strong knowledge of EU and local Regulatory Affairs requirements, including lifecycle management and marketing authorization procedures.
• Experience of reviewing promotional/medical material based on local legislation requirements

• Experience interacting with Health Authorities and managing regulatory submissions across multiple products.

• Understanding of regulatory change control processes, product information, and labelling requirements.

• Experience working effectively within cross-functional and international teams.

• Excellent planning, organizational, analytical, and problem-solving skills with strong attention to detail.

• Fluent written and spoken Greek and English, with excellent communication and stakeholder management skills.

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For information about our benefits, please click here.

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