Regulatory Affairs

2 days ago

Athens, Attica, Greece CURITY PHARMA Full time

At CURITY Pharma, we are dedicated to providing high-quality medical cannabis products to improve the health and well-being of our patients. Located in Larissa, Greece, our state-of-the-art facility adheres to strict standards of cultivation, processing, and distribution to ensure the utmost safety and efficacy of our products.

We are looking for a Regulatory Affairs Specialist to take ownership of compiling, submitting, and managing Marketing Authorisation Dossiers (MADs) for our medical cannabis products in accordance with national and EU regulatory frameworks. This individual will play a central role in bringing CURITY's pharmaceutical cannabis formulations to market.

Key Responsibilities:

  • Lead the end-to-end preparation and submission of Marketing Authorisation Dossiers (CTD format) for medical cannabis products to the Hellenic National Organization for Medicines (EOF) and other relevant European agencies.
  • Ensure full regulatory compliance across all modules.
  • Coordinate and collect input from internal departments (Quality, R&D, Manufacturing) and external partners (labs, consultants, CROs).
  • Monitor and interpret regulatory changes and guidance related to cannabis-based medicinal products.
  • Act as the primary point of contact with regulatory authorities and handle all interactions, questions, and follow-ups.
  • Maintain detailed documentation and submission timelines, and ensure 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, ideally 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 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.

Preferred Qualifications:

  • Previous experience compiling or submitting marketing authorization dossiers for cannabis-derived products.

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