Regulatory Affairs Job at Vianex SA | Apply Now
Looking for a regulatory affairs job in the pharmaceutical industry? VIANEX SA is offering an exciting opportunity for a Regulatory Affairs Coordinator in Gerakas, Attiki, Greece. This role is ideal for life sciences professionals aiming to build a strong career in regulatory submissions, dossier preparation, and global compliance. Explore how this opportunity can elevate your journey in the growing field of life sciences jobs.
- Job Title: Regulatory Affairs Coordinator
- Location: Gerakas, Attiki, Greece
About the Company
Regulatory affairs role opportunities at VIANEX SA offer a chance to work with one of Greece’s leading pharmaceutical companies. Known for its commitment to quality and innovation, VIANEX plays a significant role in the development, manufacturing, and distribution of pharmaceutical products. With a strong presence in the healthcare sector, vianex careers provide excellent pathways for professionals seeking growth in jobs in Greece and the global life sciences industry.
Job Description
Regulatory affairs job involves the preparation of product dossiers and submission to the National Organization for Medicines (EOF), the European Medicines Agency (EMA), and other relevant competent authorities for approval, variation, and renewal procedures. The role includes preparing eCTD dossiers and managing submissions through CESP, while also maintaining correspondence with partner companies and agents to obtain and provide necessary information related to dossier submissions. Additionally, the position requires the preparation and revision of SPCs (Summary of Product Characteristics) and PILs in close collaboration with the relevant Medical Affairs departments, ensuring compliance with regulatory standards in this life science job within jobs in Greece and vianex careers.
Qualifications
Regulatory affairs job requirements include:
- 2–3 years of relevant experience in a pharmaceutical company
- Degree in Biology, Biochemistry, or related Life Sciences field
- Excellent command of the English language
- Good computer literacy
Key Responsibilities
Regulatory affairs job responsibilities include:
- Preparation of product dossiers and submission to National Organization for Medicines (EOF), European Medicines Agency (EMA), or other relevant competent authorities
- Handling approval, variation, and renewal procedures
- Preparation of eCTD dossiers and submissions via CESP
- Correspondence with partner companies/agents for dossier-related information
- Preparation and revision of SPCs (Summary of Product Characteristics) and PILs
- Collaboration with Medical Affairs departments
