Greece Job Openings
Medochemie
REGULATORY AFFAIRS SPECIALIST-ATHENS
Athens
November 4, 2024
Medochemie Ltd invites applications from career oriented professionals for the position of Regulatory Affairs Specialist in our offices in Athens, Greece.
Duties:
- Implement the corporate regulatory strategy and understand requirements for the submission of relevant documentation.
- Review regulatory documentation related to Module 1 for DCP, MRP and RUP applications in line with the appropriate timelines.
- Be responsible for the submission of new dossiers, renewals and variations due to dossier updates for existing products, in e CTD format and in compliance with the global regulations in force.
- Compile and monitor the progress of responses related to Module 1 deficiencies raised by the Regulatory authorities.
- Act as a member of responsible Regulatory team who is responsible for the submission of assigned regulatory projects.
- Liaise with external Regulatory authorities as required for the successful completion of projects.
- Liaise with the appropriate departments within the company to collect all necessary information for the submission of pharmaceutical dossiers and product registration.
- Ensure policies and procedures are properly evaluated, implemented and carried out, safeguarding the compliance of company.
- Support internal activities of Regulatory department in order to ensure regulatory compliance.
- Co-ordinate and support license-out products, ensuring smooth progress of client’s procedures.
- Monitoring the progress of DCP, MRP and RUP and their finalization in a timely and accurate manner.
- University degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology, etc). A post graduate degree will be considered an asset.
- At least 2-3 years of experience in the pharmaceutical sector, in the field of generic product development, Regulatory Affairs.
- Knowledge and practical understanding of EU and non-EU pharmaceutical legislation, EMA & ICH relevant guidelines.
- Ability to work collaboratively in a team, and prioritize work in a dynamic and fast changing environment.
- Strong communication, influencing and problem resolution skills.
- Strong organization skills and able to meet deadlines.
- Ability to be adaptive to change, to multitask and give attention to detail.
- Very good interpersonal skills, analytical thinking and result orientation.
- Fluency in Greek and English (written and spoken) and computer literacy. Knowledge of any other languages will be considered an asset.
- Ability to travel abroad if requested.
We are offering an attractive remuneration package (including medical insurance) and a challenging opportunity for professional development.
If you wish to work in a pleasant, modern, professional environment with excellent career opportunities, please click buttons below.
Applicants should note that based on the General Data Protection Regulation (GDPR), all applications/CV’s kept in our database have been deleted. In case you have forwarded us your CV in the past and you are interested in this position, please apply again.
All applications will be treated in strict confidence.
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