Regulatory Affairs Non-EU Senior Officer

ANFARM Hellas SA, an EU GMP Pharmaceuticals Manufacturer, is a highly reputable manufacturer of generic pharmaceuticals with an extended export activity worldwide.  REGULATORY AFFAIRS NON-EU SENIOR OFFICER  with accountability for managing and executing of the full RA life cycle across multiple simultaneous projects. Main duties and responsibilities:Planning and execution of all regulatory activities linked to National procedures, according to Non-EU legislation and global national guidelines.Collect, prepare, compile regulatory documentation, for the product’s full lifecycle maintenance (initial Marketing Authorization, variations, and renewal procedures).Communication with Health Authorities and partners for the successful registration of products and the full lifecycle management.Liaise with various departments for the collection, preparation, review, and compilation of regulatory documentation.Handling of responses to DL’s liked to initial submissions, variations, or renewals.Preparation and compilation of m1 of the CTD dossier.RA database maintenance for designated projects Experience & Qualification:University Degree in Life Sciences e.g. Pharmacy, Biology, Chemistry etc. (M.Sc. will be considered an asset).At least 2 years of experience in Non-EU Regulatory Affairs.Good knowledge global regulations, guidelines, and procedures relevant to pharmaceutical product registration.Excellent command of English language, both verbally and written.PC skills (MS office etc.).Organizational, planning, and problem-solving skills.Effective cross-functional communication.Teamworking spirit, capable of handling tasks efficiently and under minimal supervision. Ability to work equally well independently or as a member of a team.Ability to deliver high quality work, in a timely manner and to specific deadlines.