WOULD YOU LIKE TO HAVE A SUCCESSFUL INTERNATIONAL CAREER?
International pharmaceutical company KRKA has a newly established subsidiary in Athens, therefore we have an open position for an REGULATORY MANAGER (m/f)
KRKA Group is one of the world’s leading generic pharmaceutical companies, focusing on generic prescription pharmaceuticals marketed under its own brands. It is a company with a 65 years old tradition with headquarters in Slovenia. More than one half of 12,500 employees, work in 45 subsidiaries and representative offices abroad. Our medicines are used to treat more than 50 million patients every day in over 70 markets ranging from Lisbon to Vladivostok. More information about the company you can find on www.krka.biz.
YOUR RESPONSIBILITIES
- Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases
- Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Greek medicine agency
- Participating in the preparation of regulatory strategy for Greece together with global regulatory strategy of the company
- Planning, coordinating and supervising all activities needed for obtaining marketing authorizations
- Communication with local authorities
- Working closely with Regulatory affairs, Pharmacovigilance and QA headquarters and reporting to them
- Translations of SPCs, leaflets and labelling from English to Greek language and vice versa
- Reviewing approved product information in post-registration/production phase
- Preparation and implementation of SOPs and work instructions in line with global policy and local requirements for regulatory and QA fields
- Training fellow workers for the implementation of new methods, work technologies and SOPs
- Close work with management and marketing for evaluation of new products
- Submitting pharmacovigilance documentation to the relevant state institutions and transfer of received pharmacovigilance information to the qualified person responsible for pharmacovigilance in HQ
OUR EXPECTATIONS
- Master degree with major Pharmacy, Chemistry, Medicine, Vet medicine, Biology
- Experience in management of regulatory affairs, desired in international company
- Knowledge of local and international regulatory procedures and relevant legislation
- Experiences working with local authorities in Greece
- Experiences in pharmacovigilance
- IT knowledge (relevant database systems)
- Fluent in English (speaking, reading and writing)
- A person who is team oriented, accurate and good with details, self-initiative, organized and efficient, able to meet deadlines and has an honest, transparent attitude and communication
OUR OFFER
- Professional and personal development, career growth
- Regular on job trainings
- Competitive salary
- Working in the one of the most efficient regulatory team in the EU
- Work in international business environment .
We are looking forward to receiving your application with your CV in English till April 3rd, 2020, mentioning position Regulatory Manager to: info.gr@krka.biz.
