Regulatory Affairs and Lifecycle Management (LCM) Manager

Galenica is a dynamic and fast-growing Greek pharmaceutical company with a strong local presence and extensive export activity across international markets. We are seeking an experienced and motivated Regulatory Affairs and Lifecycle Management (LCM) Manager to join our Regulatory Affairs Department.

Key Responsibilities

• Lead regulatory strategy and lifecycle management activities for medicinal products across EU and international markets.
• Manage and coordinate Marketing Authorization Applications (MAAs), variations, renewals, transfers, and discontinuations through NP, MRP, DCP, and CP.
• Liaise with Health Authorities, partners, clients, and third parties to ensure successful execution of regulatory projects and submissions.
• Act as the regulatory contact person for medical device-related activities ensuring compliance with applicable MDR requirements.
• Coordinate and compile responses to regulatory authority questions, deficiency letters, and other regulatory communications.
• Support lifecycle management activities, ensuring continued compliance of product information, labeling, and technical documentation with applicable regulatory requirements.
• Review technical and regulatory documentation to assess potential regulatory impact on marketed products and ongoing submissions.
• Develop and maintain Regulatory Affairs policies and procedures, ensuring compliance across pharmacovigilance, quality, and business activities.
• Participate in regulatory safety communications where required.
• Monitor and interpret EU and international regulatory legislation, guidelines, trends and updates, ensuring organizational awareness and compliance.
• Identify regulatory training needs and support the delivery of internal training activities where appropriate.
• Contribute to regulatory strategy assessments for new business opportunities, product development projects, and market expansion activities.
  
  

Qualifications

• Degree in Pharmacy, Chemistry, Biology or other relevant Life Sciences discipline.
• Master’s degree or PhD will be considered an asset.
• Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Proven hands-on experience with EU and international regulatory procedures including lifecycle management activities.
• Good knowledge of EU pharmaceutical legislation, ICH guidelines, and Medical Device Regulation (MDR) requirements.
• Familiarity with eCTD submissions and regulatory publishing processes.
• Fluency in Greek and excellent command of English, both written and spoken.
• Proficiency in MS Office applications and general computer literacy.
• Strong organizational, communication, analytical, and problem-solving skills.
• Ability to manage multiple projects effectively in a fast-paced environment.
• Commitment to quality, compliance, and continuous improvement.
• Team-oriented mindset with strong interpersonal skills and attention to detail.
  
  

Company Offers

• Competitive remuneration package.
• Private medical health insurance.
• Dynamic and collaborative working environment.
• Professional growth and career development opportunities.