A Greek pharmaceutical company, with a continued presence in the Greek and international pharmaceutical market up to the present day, is seeking for a Regulatory Affairs Senior Officer.

Main Purpose:

The Regulatory Affairs Senior Officer will provide direct regulatory support to various projects and products, both new and existing.

Key responsibilities

• Compiling relevant documentation, in accordance with NTA and ICH guidelines intended for Pharmaceutical Dossier submission and product registration and support internal activities of Regulatory department in order to ensure regulatory compliance of registered and on market products.
• Update existing technical dossiers (Modules 1, 2.3, 3) of pharmaceutical products, in order to comply with current EU requirements or other country specific requirements (for non-EU registrations) to support Out-Licensing activity.
• Communication and close collaboration with all involved departments of the company and all external parties in order to collect the required data for registration of CTD dossiers and e-CTD, responses to authorities’ questions, filling variations, maintaining timelines of projects.
• Responsible for the filing in due dates and for handling correspondence with the competent authorities.
• Life cycle management of marketing authorizations, by preparing for submission of appropriate variations for post approval changes of the CTD dossiers, renewals and rest of Life cycle management activities.
• Drafting, regulatory review, and approval of labelling, assuring its compliance with the guidelines issued by the EU or the Regulatory Authorities of non-EU countries.

Requirements & Skills

• Bachelor’s Degree in Chemistry, Biology or Pharmaceutical Studies.
• 2 years’ previous experience in RA and/or RnD department.
• Knowledge of EU regulatory framework, ICH and EU requirements of GMP & GLP.
• Excellent knowledge and handling of both verbal and written English language.
• Good knowledge of MS Office suites (Word, Excel, Power Point, Outlook).
• Ability to multi-task, work both independently and in a team environment.
• Strong communicational skills.

Private Health Assurance Provided.