Τοποθεσία Αθήνα πριν 4 μέρες Ημ. ανάρτησης πριν 4 μέρες Με κάποια εμπειρία Επίπεδο εμπειρίας Με κάποια εμπειρία Πλήρης απασχόληση Τύπος απασχόλησης Πλήρης απασχόληση Φαρμακευτικά / Υγεία Κατηγορία θέσης Φαρμακευτικά / Υγεία
Pharma Path, 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 Pharma Path and its clients in e CTD 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 Qo S) 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