Regulatory Affairs Manager Greece Cyprus Malta

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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.

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.