Regulatory Affairs and CMC Officer
based in Athens, Greece.
Role Description Summary:
The position resides within the Regulatory Affairs and CMC department and it involves new and marketed products support as it pertains all regulatory activities and requirements throughout the pre-registration, registration, post-approval, and life cycle management of pharmaceutical products.
The candidate is expected to remain current with regards to regulations, guidelines and policies for the pharmaceutical/manufacturing areas and to develop advanced skills such as interpreting and advising on the complex and evolving regulatory and CMC requirements.
- Communication and close collaboration with all involved departments of the company and all external parties in order to collect the required data for EU and RoW registration of eCTD dossier, responses to authorities’ questions, filling variations, maintaining timelines of projects.
- Compiling relevant Module 1 documentation, in accordance with NTA and ICH guidelines intended for Pharmaceutical Dossier submission and product registration.
- Support internal activities of Regulatory department in order to ensure regulatory compliance of registered and on market products.
- 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.
- Compilation and monitoring of the progress of scientific responses to deficiencies raised by the regulatory agencies.
- Review, edition and creation of e-CTD regulatory submissions.
- Communication and relative support of clients’ submissions.
Job Qualifications & Requirements:
- University Degree in Chemistry, Chemical Engineering, Biology or Pharmaceutical Studies.
- At least 2 years’ previous experience (pre & post approval) in regulatory and/or CMC 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 work accurately in a busy and demanding environment, adhering to strict deadlines/timescales.
- Flexible and strong communicational skills
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