Medochemie Ltd is an International Pharmaceutical Company headquartered in Cyprus. Medochemie manufactures a wide range of products divided into more than 10 therapeutic categories, owns 3800 marketing authorizations and operates in more than 107 countries around the world. Our thirteen separate manufacturing sites are designed to fully comply with European and WHO current Good Manufacturing Practice (cGMP).
Medochemie Ltd invites applications from career oriented professionals for the position of Regulatory Affairs Senior Specialist in our offices in Athens, GREECE.
The position:
- Supervise and coordinate a team of specialists for the CMC dossier compilation and dossier updates for existing products, in eCTD format in compliance with the global regulations in force.
- Supervise the submission and follow up till approval of Marketing Authorisation Applications (MAAs) mainly for European Registration Procedures (DCP/MRP) but also non-EU national procedures according to the company’s strategy, considering the different country specific requirements.
- Ensure the successful maintenance of dossiers’ and MAs’ lifecycle (variations & renewals) in all territories as necessary so that the MAs are up to date.
- Establish regulatory priorities and ensure the team’s milestones/goals are met and adhering to departmental objectives and corporate strategies.
- Implement departmental policies and procedures to ensure that regulatory compliance is maintained and enhanced.
- participate in developing Regulatory strategies within the department, interact and negotiate with competent Authorities and maintain close working relationship with internal stakeholders ( e.g. QA, QC, production, commercial) for the preparation review and compilation of regulatory documentation
- participate in cross functional teams within the company for the implementation, follow up and completion of cross functional projects Provide regulatory guidance and communicate regulatory information to different departments
The candidate:
An adaptive to change, ability to multitask and attention to detail personality with good communication, interpersonal, influencing and problem resolution skills.
- University degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology, etc). A post graduate degree will be considered an asset.
- Previous Regulatory Affairs/CMC/ product development experience as a Supervisor/Manager within generic Pharmaceutical industry
- Extended Knowledge and practical understanding of EU and non-EU pharmaceutical legislation, EMA & ICH relevant guidelines and competency with e-CTD preparation
- Ability to lead collaboration in a team, delegate responsibilities and prioritize work in a dynamic and fast changing environment.
- Organizational, planning, problem-solving analytical thinking and cross functional skills
- 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
Location: Athens, GREECE.
We are offering an attractive remuneration package and challenging opportunity for professional development.
If you wish to work in a pleasant, modern, professional environment with excellent career opportunities, please click Submit your CV or Fill in the online Form 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.
