Senior Regulatory Affairs Expert
1 day ago
We are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory frameworks and be able to effectively manage Marketing Authorisation Dossiers (MADs) for medical cannabis products.
The successful candidate will lead the end-to-end preparation and submission of MADs to national and EU regulatory agencies, ensuring full compliance across all modules. This includes coordinating with internal departments and external partners to collect input and monitor regulatory changes.
In addition to these responsibilities, the Regulatory Affairs Specialist will serve as the primary point of contact with regulatory authorities, handling all interactions, questions, and follow-ups. They will also maintain detailed documentation and submission timelines, ensuring version control and audit readiness at all times.
Requirements- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related field.
- Minimum of 3 years' experience in Regulatory Affairs, preferably with direct experience in the medical cannabis sector or controlled substances.
- Strong understanding of Greek regulatory requirements for pharmaceutical products.
- Familiarity with GACP/GMP compliance and relevant guidance for cannabis-based medicines.
- Excellent written and verbal communication skills in both English and Greek.
- Strong attention to detail, ability to manage deadlines, and a proactive, solutions-oriented mindset.
- Excellent leadership, communication, and interpersonal skills, with the ability to effectively lead and motivate a diverse team.
- Previous experience compiling or submitting marketing authorization dossiers for cannabis-derived products.
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