Regulatory Affairs CMC Specialist

Regulatory Affairs CMC Specialist

Location: Peristeri, Attica, Greece

Employment Type: Full-time

About the Role

We are seeking a Regulatory Affairs CMC Specialist to join our Regulatory Affairs team. The successful candidate will be responsible for managing and supporting regulatory activities, ensuring that company products remain compliant with applicable national and international regulatory requirements.

This role offers the opportunity to work in a dynamic pharmaceutical environment, collaborating with cross-functional teams and contributing to both European and international regulatory projects.

Key Responsibilities

• Preparation & coordination of national and European regulatory submissions, including Letters of Deficiencies
• Lifecycle management, including Variations, Renewals, and Marketing Authorization Transfers.
• Communication with national and international regulatory authorities, including the National Organization for Medicines (EOF), EMA, and other competent authorities.
• Monitor, assess, and implement new regulatory requirements and guidelines.
• Collaboration with R&D and other relevant cross-functional departments, Contract Manufacturing sites & clients.
• Maintenance and update regulatory documentation, databases, and internal records to ensure regulatory compliance.
• Dossier audits

Required Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 2 years of experience in Regulatory Affairs CMC within the pharmaceutical industry.
• Good knowledge of the European and Greek pharmaceutical regulatory framework.
• Experience with CTD/eCTD dossier preparation and submissions.
• Excellent written and spoken English.
• Proficiency in Microsoft Office applications.
• Strong organizational skills, attention to detail, and the ability to manage multiple deadlines effectively.

Preferred Qualifications

• Experience with Decentralized Procedure (DCP) and Mutual Recognition Procedure (MRP) submissions.
• Familiarity with Regulatory Information Management Systems (RIMS).
• Master's degree in Regulatory Affairs or a related scientific field.
• Experience supporting regulatory submissions and lifecycle management activities for the United States (US) and Rest of World (RoW) markets.

What We Offer

• Competitive compensation package.
• Private health insurance.
• Company-sponsored retirement plan.
• Meal vouchers (Ticket Restaurant).
• Modern and dynamic working environment.
• Professional development and continuous training opportunities.
• Participation in international projects and collaborations.
• Remote work flexibility

The final compensation package will be determined based on the candidate’s professional experience, qualifications, and overall assessment, in accordance with the company’s compensation policy and applicable employment legislation.

Candidates' personal data will be processed solely for recruitment and selection purposes related to the present vacancy and will be retained in the Company's records for a period of five (5) years.

Equal Employment Opportunity

The company is committed to providing equal employment opportunities to all applicants and employees, without discrimination based on gender, age, national or ethnic origin, religion or belief, disability, sexual orientation, or any other characteristic protected by applicable law.

Candidate selection is based exclusively on qualifications, skills, experience, and suitability for the position.