Medochemie is an International Pharmaceutical Company, one of the top 200 producers of generic drugs globally, exporting its products to 110 countries, thus holding the 29% of the total industrial exports of Cyprus. Medochemie operates 13 ultramodern manufacturing plants, 9 in Cyprus, 3 in Vietnam and 1 in the Netherlands, all designed in accordance with GMP (Good Manufacturing Practice) of the EU and WHO (World Health Organization, operates in 22 countries and employs a global workforce of 1880 employees of 19 ethnicities.

We ‘re on a mission to find the best talent out there. Our Regulatory Affairs Department is expanding its activities, building new processes and systems, so we are looking for experienced RA Senior Professionals at different levels, Specialist, Senior Specialist or Assistant Manager to join our team in our offices in Limassol, Cyprus.

What the job looks like?

Depending on the experience level, the RA Senior Professionals will have the opportunity to:

• To submit or supervise the submission Marketing Authorisation Applications (MAAs) for both European Registration Procedures (DCP/MRP) and non-EU national procedures according to the commercial strategy of Medochemie Ltd, considering the different country specific requirements.
• To timely submit or supervise the submission of the necessary lifecycle regulatory activities (renewals and variations) in all territories as necessary so that all Marketing Authorisations are up to date
• Evaluate deviations to the relevant documentation, identifying regulatory actions required for the marketed products.
• Be responsible for compilation of dossiers for new products and dossier updates for existing products, in CTD and eCTD format and in compliance with the global regulations in force.

• Be responsible for data evaluation and review of CMC relevant documentation in line with internal procedures and relevant guidelines for the dossier submission fulfilling key milestones and being accountable for the quality and compliance of submissions.

• Have a key role representing the Regulatory Affairs team in the Interdepartmental discussions on issues affecting interdepartmental projects. Provide regulatory guidance and communicate regulatory information to different departments
• Maintain knowledge of the regulatory environment, regulations, and guidance. Identify potential approval risks for ongoing projects based on changes to regulations and/or standard.
• To participate in various internal projects for RA digital transformation in order to build processes and systems to future proof the regulatory framework in the upcoming digital era

• What does it take to do the job?

• Bachelor’s degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology, etc); post graduate degree will be considered as advantage
• At least 3 years of experience in a similar role; experience in the pharmaceutical sector is a must
• Knowledge and practical understanding of EU and non-EU pharmaceutical legislation, EMA & ICH relevant guidelines
• Highly organized, ability to multitask and prioritize work in a dynamic and fast changing environment
• Ability to lead collaboration in a team and delegate responsibilities
• Analytical thinking and results-oriented mindset
• Outstanding communication skills
• Able to cope under pressure and tight deadlines
• Fluency in Greek and English (written and spoken)
• Strong computer literacy

By joining us you can expect:

• A unique opportunity for a career in a fast-growing company
• Competitive remuneration package based on qualifications and experience
• 13th Salary
• Modern & Professional Work Environment
• Multiple events to bond with the team
• Participation in the Company’s Provident fund where the employer contributes 7% of the monthly salary
• Optional participation in the Company’s Group Medical Scheme, and Discount Scheme
• Opportunities to learn and develop yourself through our ‘Employee Training & Development Path’

If you believe that you have the above qualifications and this opening sounds challenging, apply now by uploading your cv below or by completing the online application.

Applicants should note that based on the General Data Protection Regulation (GDPR), all applications/CVs are kept in our database based on the consent period each candidate applied for. In case you have forwarded us your CV in the past and you are interested in this position, please apply again.

Department: Regulatory Affairs

Location: Limassol

Employment Status: Full Time

All applications will be treated with strict confidentiality. Only shortlisted candidates will be contacted.