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 15 ultramodern manufacturing plants, 9 in Cyprus, 5 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.

Medochemie Ltd invites applications from career-oriented professionals for the position of Regulatory Affairs Specialist in our offices in Limassol.

What the job looks like?

The RA Specialist will have the opportunity to:

• Responsible for the compilation of dossier sections and sourcing of relevant documentation for modules 2-5 of Medochemie dossiers intended for registration for Medochemie or clients at global scale in eCTD format
• Compilation of responses and scientific documentation at correspondences with authorities or clients related to initial submissions, and the lifecycle of submissions i.e. variations, renewals, upgrades and new developments. Monitoring the progress of responses related to Modules 2-5 deficiencies raised by the regulatory authorities
• Review of quality documentation related to Modules 2-5 for the applications in line with the appropriate guidelines and timelines
• CMC regulatory directions provision at the various company departments, external parties and suppliers for the projects which have been assigned
• Liaise with the appropriate departments within the company and external parties to collect all necessary information for the submission of pharmaceutical dossiers and product registration
• Assist in keeping the dossier core files (Modules 2-5 and corresponding QoS) fully up to date during registration procedures and variations
• Continuous follow up of the regulatory affairs activities of all projects that have been assigned. Update of the regulatory database in collaboration with the regulatory partners. • Understand and use the EU and International Regulatory guidelines
• Participate in the change control system and variation process according to the established internal workflow
• Participate in regulatory affairs internal projects of digital transformation, namely Regulatory Information management system and Submission Document Core Model
• Act as a member of responsible Regulatory team who is responsible for the submission of assigned regulatory projects
• Liaise with external Regulatory authorities and/or clients if required for the successful completion of projects
• 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
• Monitoring the progress of the assigned projects and their finalization in a timely and accurate manner

What does it take to do the job?

• 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/CMC
• 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

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.