Regulatory Affairs Specialist / Senior Specialist

Location: Athens, Greece

A Leading Pharmaceutical Company, committed to enhancing the well-being of patients and consumers through innovative health solutions, is seeking a highly motivated and experienced Regulatory Affairs Specialist to join our Regulatory Affairs Department. The successful candidate will be responsible for the preparation, submission, and lifecycle management of regulatory dossiers, ensuring full compliance with national and European regulatory requirements. This role offers the opportunity to work in a dynamic, collaborative, and international environment.

Key Responsibilities

• Prepare, review, and submit Marketing Authorization Applications (MAAs), variations, renewals, and other regulatory submissions.
• Act as the main point of contact with national and EU regulatory authorities, as well as internal and external stakeholders.
• Monitor changes in legislation and guidelines, ensuring timely implementation within the company.
• Provide regulatory support to cross-functional teams including Quality Assurance, Pharmacovigilance, Medical, and Commercial.
• Manage regulatory activities across the entire product lifecycle, from development to post-marketing.

Qualifications & Requirements

• University degree in Pharmacy, Chemistry, Biology, or related scientific discipline.
• Minimum 4 years of proven experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of national and EU regulatory frameworks.
• Excellent command of English, both written and verbal.
• Strong organizational skills, attention to detail, and ability to manage multiple projects effectively.
• Excellent communication skills and ability to work collaboratively in cross-functional teams.