CMC Regulatory Compliance Officer

Pharmathen

Μαρούσι, Αττικής
Μόνιμη
Πλήρης Απασχόληση

Πριν 17 ημέρες
Κάντε αίτηση εύκολα

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 Regulatory Compliance Officer to join our Regulatory Affairs team at Pharmathen’s Marousi premises.As a CMC Regulatory Compliance Officer, you will be responsible for supporting all post approval CMC activities and act as a liaison person with all relevant departments within Pharmathen as well as suppliers.More particularly:What you’ll do:

Keep abreast of international legislation, guidelines and customer practices
Collect and collate a wide range of product technical information and ensure compliance with all relevant quality guidelines applicable
Be responsible for preparation of quality variations packages and renewals for DCPs/MRP/CPs and national applications within strict deadlines
Participate in teleconferences and/or meetings with the regulatory authorities within EU, suppliers, clients

RequirementsThe ideal candidate should have:

Minimum of a Bachelor’s Degree in a scientific discipline (preferably Chemical Sciences, or Biochemistry)
2-3 years of relevant experience in the pharmaceutical area
Previous experience in analytical chemistry (eg HPLC) will be considered an asset

Job-Specific Skills:

Excellent communication in English language (writing & speaking)
Ability to prioritize tasks and meet deadlines
Computer literacy
Project management
Multi-tasking
Time managementskills

BenefitsWhat you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career!Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

Pharmathen