Main duties & key responsibilities:
- Lead the preparation, compilation, and submission of pharmaceutical CTD dossiers (Module 3) for PharmaPath and its clients in eCTD format, ensuring compliance with global regulatory requirements.
- Oversee the life-cycle management of worldwide product registrations, including variations, renewals, and post-approval changes.
- Respond to queries (from regulatory authorities or clients) concerning dossiers, manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions to respond as rapidly and completely as possible
- Assist in keeping the dossier core files (Module 3 and corresponding QoS) fully up to date during registration procedures and because of variations
- Participate in meetings related to registration procedures or when the CMC expertise is needed. Tightly collaborate with the RA and R&D Departments for assigned products
- Mentor and provide guidance to junior members of the CMC team, fostering a culture of collaboration and knowledge sharing.
- Prepare the variation and post-approval change packages and other necessary documents as required by the variation process
- Ensure that all documents and records pertaining to the CMC Department are archived properly. Keep departmental database or other tracking system up to date
- Review regulatory compliance protocols and/or reports, as requested
- Participate in the change control system and variation process according to the established workflow and contributing to renewal applications
Requirements:
- Bachelor’s degree in Chemistry, Pharmacy, Biochemistry, or related scientific discipline. A postgraduate degree will be considered an asset.
- Minimum 5 years of hands-on experience in Regulatory Affairs CMC activities, including full dossier compilation, life-cycle management, and variation procedures.
- Knowledge of the Generic Legislation and Pharmaceutical Registration Guidelines, Directives as stated by European & National Regulatory Authorities
- Knowledge of the scientific (chemistry, manufacturing, control) documentation and registration requirements of the generic pharmaceutical products CTD dossier
- Strong organizational skills. Proven ability to plan, prioritize, and execute projects effectively within deadlines. Demonstrated problem-solving skills and capacity to work independently with minimal supervision
- Superb communication skills are required to liaise effectively with colleagues, clients, regulatory agencies, both verbally and in writing
- Excellent knowledge and handling of both verbal and written English language. Knowledge of any further language is an advantage
- Excellent knowledge of the MS Office tools (Word – Excel – Outlook – Internet explorer)
Benefits:
- Competitive remuneration package, including benefits
- Ability to become part of one of the most dynamic and prospective teams in the Pharmaceutical industry in Greece
- Continuous opportunities in advancing personal and career goals
To apply, kindly submit your CV at HR@PharmaPath.eu referencing the code CMCS/11.
Based on your consent all received applications will be stored in our database for maximum 6 months and all data will be treated with strict confidentiality commensurate to data protection regulation.
