Lavipharm is seeking a Senior Specialist Regulatory Affairs, Pre-Authorization Submissions based in Athens, who will play a central role in progressing the pipeline and expanding the current portfolio into new markets. In relation to Pre-Authorization Submissions, the role will lead the preparation and coordination of CTD/eCTD dossiers for new marketing authorization applications, working closely with cross-functional teams to drive submissions through to approval. The role operates with a high degree of independence, engages directly with regulatory authorities and provides strategic input to the submission process.
Key Responsibilities
- Leads preparation, review and compilation of CTD/eCTD dossiers for new product applications (MAAs and MATAs)
- Authors and reviews Module 1 documentation with minimal supervision, including regional/administrative content
- Contributes to regulatory submission strategy and drives proactive project completion
- Liaises directly with regulatory authorities during evaluation phases; prepares responses to questions and requests for information
- Coordinates across functions with key internal stakeholders to ensure dossier completeness and guideline compliance
Requirements
- BSc in Pharmacy, Chemistry, Biology or a related field (post-graduate decree is a plus)
- 3–5 years of experience in Regulatory Affairs, with a focus on pre-authorization or new product submissions
- Strong knowledge of EU/ICH regulatory requirements, CTD/eCTD format and submission processes
- Excellent command of the Greek and English language (written and spoken)
- Strong computer literacy
- Proven ability to manage multiple projects, handle competing priorities and work under pressure
