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, 5in 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 Specialist to join our team in our offices in Limassol, Cyprus.
What the job looks like?
The RA Specialist 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
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
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 and 14th 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.
http://www.medochemie.com/MainMenu/Careers.aspx
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.
Οι ενδιαφερόμενοι υποψήφιοι παρακαλούνται να στείλουν το βιογραφικό τους στον Διευθυντή Ανθρώπινου Δυναμικού στο HR.Cyprus@medochemie.com.
MEDOCHEMIE was established in 1976 in Cyprus by Dr. Andreas Pittas and is still driven by the same philosophy: "To provide every human being around the globe with quality and affordable drug treatment".
We develop, license, manufacture, market, and distribute branded generic and super-generic pharmaceutical products as well as our own patented brands.
The journey has seen our active expansion into promising markets across the world – from our base in Europe, to the Middle East & Africa, through to the Far East.
Outside our 20 core offices, we developed a network of trusted agents and partners allowing us to operate in more than 100 countries. Today, Medochemie Ltd has eleven manufacturing plants and facilities.
Nine are in Cyprus, one in the Netherlands, and one in Vietnam. We have acquired and maintain 3,800 marketing authorization licenses for 630 different pharmaceutical products, classified in over 10 therapeutic categories.
We operate in accordance with the strictest quality standards and in full compliance with European guidelines. The driving force behind Medochemie is our 1,250 multinational, talented, quality-focused employees, who work in our manufacturing plants and offices worldwide.
Medochemie is a founding member of the European Generic Medicines Association (EGA).
