Regulatory Affairs Senior Officer

DescriptionFounded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.Pharmathen’s highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to 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 Regulatory Affairs Senior Officer to join our Regulatory Affairs team at Pharmathen’s Marousi premises.As a Regulatory Affairs Senior Officer the ideal candidate will be responsible for submitting applications for marketing authorizations and for lifecycle management of the MAs (renewals/variations). You will also act as a liaison person with regulatory authorities/clients.More ParticularlyWhat you’ll do:Keep abreast of international legislation, guidelines and customer practicesCollect and collate a wide range of product information and ensure compliance with all relevant guidelines Be responsible for preparation (module 1) and coordination/submission of Deficiency Letter (DL) responses Submit new marketing, variation, and renewal applications to authorities within strict deadlinesNegotiate with regulatory authorities for marketing authorizationParticipate in teleconferences and/or meetings with the regulatory authorities, suppliers, clientsFollow up of applications and maintenance of relevant databases RequirementsThe ideal candidate should have:Minimum of a Bachelor’s Degree in a scientific discipline (preferably Chemical Sciences, or Biochemistry)2-3 years relevant experience in the pharmaceutical areaJob-Specific SkillsExcellent communication in English language (writing & speaking)Computer literacyMulti-taskingTime management Ability to prioritize work and meet deadlinesBenefitsWhat you'll gain:Involvement in a high-caliber, team-oriented and dynamic atmosphereExposure to challenging business issues and practicesGreat opportunity to leverage and develop your business knowledge and skillsJoin 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.