Regulatory Manager
On-site · Athens, Attica, Greece
Job Summary
Lead regulatory affairs for defined portfolios in Greece & Cyprus, ensuring products are launched and maintained in compliance with local requirements while supporting business growth. Responsible for preparing regulatory documents, dossiers, and applications, obtaining authorizations, handling registrations/variations/renewals, approving labeling and artwork, managing labeling/text and packaging compliance, reviewing promotional materials for regulatory alignment, and communicating risks. Collaborates with marketing, supply chain, and QA to deliver compliant innovation and value engineering projects, maintains regulatory databases, and supports cross‐functional changes while staying current with regulatory changes.
Required Qualifications
- Bachelor’s degree in life sciences or related pharmaceutical field
- Minimum 5 years’ experience in Regulatory Affairs
- Fluent written and verbal English
- Knowledge of lifecycle requirements for regulated products
- Understanding regulatory requirements for medicines
- Understanding needs in different business models – e.g. distributor model, external regulatory vendors
- Knowledge of regulatory strategy for filing of submissions
- Excellent interpersonal, time management, organizational and communication skills
- Significant general computer literacy including Microsoft Office
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