Regulatory Associate

Krka is one of the leading generic pharmaceutical companies in the world. We have now been successfully implementing our strategies and pursuing our mission and vision for more than 60 years. Krka’s basic line of business is the production and sale of prescription pharmaceuticals, non-prescription products and animal health products. The company’s activities are supplemented by health resort and tourist services. Our products are sold in over 70 countries.
We invite you to join our team where partner relationships are based on mutual trust and respect and offer dynamic work on challenging and motivating projects.
For our affiliate company KRKA ČR, s. r. o., based in Prague we are searching for Regulatory Associate.For more information visit http://www.krka.biz/en/.

 

Key responsibilities:
• Reviewing and maintaining knowledge about regulatory regulations
• Preparing regulatory activity plans for selected products on request
• Preparing in cooperation with R&D, Marketing, and Sales the registration documentation and translations into local language
• Submitting registration documentation to authorised state institutions if needed
• Recording, filing and distributing marketing authorisation approvals (Krka d.d.)
• Preparing, collecting and reviewing documentation (drug master file), consistent with legislation, and if needed additionally assembling the documentation
• Preparation of payment forms

The ideal candidate will have:
• Experiences with work in regulatory field (optimally 2 years)
• University degree in one of the following fields: pharmacy, chemistry, medicine, veterinary medicine, other natural sciences
• Fluent Czech and English /written and spoken
• Detailed oriented with good administrative skills
• No Criminal Record


What we offer:
• Interesting and dynamic work in a professional team in an international company
• Possibility of professional growth and training program
• Competitive remuneration
• Notebook and mobile phone (with a discounted tariff) also for private purposes
• 5-weeks holiday per year
• Meal vouchers in amount of 80 CZK for each working day (full tax covered by company)

If you are interested in working with us please send your CV to hana.zlomkova@krka.biz