PharmaPath, a Greek pharmaceutical company with a rich history and significant legacy in the pharmaceutical field of generic medicines, is seeking a dedicated and skilled CMC Specialist to join our dynamic team. 

Main duties and responsibilities:

• Compiling pharmaceutical CTD dossiers of PharmaPath and its clients in eCTD format, follow up until MAs are granted, and life-cycle maintenance of the world-wide registration of pharmaceutical products in regard to chemistry, manufacturing, control related documentation
• Assist in the collection and evaluation of data to be included in module 3 of marketing authorization dossiers
• 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
• 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, Biochemistry, Pharmaceutical Studies or related sciences. A relevant postgraduate degree is considered an asset
• Minimum 2 years of experience in Regulatory Affairs CMC position, covering the full range of CMC regulatory activities (compilation of module 3, life-cycle management etc)
• 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