CMC New Products Oral Officer

Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.

Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.

Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to attract a CMC New Products Oral Officer to join our CMC & Quality Affairs New Products team at Pharmathen’s Metamorfosi premises.

As a CMC New Products Oral Officer, you will support all pre-approval CMC applications through compiling of the quality part of the dossier (module 2-5) of each product, preparing the responses to DLs. Overall you will be responsible for all necessary activities until the MA is granted.

More particularly:

What you’ll do:

• Keep abreast of international legislation, guidelines and customer practices
• Compile product registration dossier (module 2-5) for submission to the regulatory authorities worldwide
• Be responsible for responding to DL of new product applications (quality part)
• Ensure quality compliance of all documents as per the relevant guidelines.
• Act occasionally as a liaison with regulatory authorities and customers
• Participate in t/c and/or meeting with the regulatory authorities, suppliers, clients and with other departments within the company