Krka d.d. is one of the leading generic pharmaceutical companies in the world. We have been successfully implementing our strategies and pursuing our mission and vision for more than 65 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. For more information visit http://www.krka.biz/en/."
REGULATORY AFFAIRS MANAGER
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 Affairs Manager.
• Conducting and implementing registration procedures according to the selected scenario and in line with the current legislation and deadlines for human and veterinary pharmaceutical products
• Monitoring local pharmaceutical legislation in the regulatory field and monitoring the practice and trends of the Czech medicine and veterinary agency
• Planning, coordinating and supervising the activities needed for implementing and obtaining marketing authorisations for human and veterinary pharmaceutical products
• Communication with local authorities
• Preparation and implementation of SOPs and work instructions in line with global policy and local requirements for regulatory and QA fields
• Translations of SPCs leaflets and labelling from English to Czech and vice versa.
• Approving the artworks before the production
• Running and maintaining data bases
• Submitting pharmacovigilance documentation to the relevant state institutions and transfer of received pharmacovigilance information to the qualified person responsible for pharmacovigilance in the HQ
• Working closely with Regulatory affairs headquarters, local management, sales and marketing and reporting to them (cooperation in small team - in future leading)
• Warehouse QP – fully responsible person
• All other tasks assigned by superiors and consistent with employee’s qualifications and needs of the work process.
The ideal candidate will have:
• Experiences with work in regulatory field at least 5 years (experience in management of regulatory affairs and leading the team is advantage)
• University degree in one of the following fields: pharmacy, chemistry, medicine, veterinary medicine, other natural sciences
• Knowledge of local and international regulatory procedures and relevant legislation, experiences in PV
• Fluent Czech and fluent English (written and spoken form)
• Detailed oriented person with good administrative skills and IT skills (relevant database systems)
What we offer:
• Interesting and dynamic work in a professional team in an international company (leading small team in future)
• Possibility of professional growth and training program
• Competitive remuneration
• Computer, car and mobile phone
Informace o pozici
- KRKA ČR, s.r.o.
- Sokolovská 192/79, Praha – Karlín
- Required education: University
- Required languages: English (Proficient)
- Benefits: Car for private purposes, Cell phone, Notebook, Meal tickets / catering allowance, Holidays 5 weeks
- Listed in: Research and development, Pharmaceutical, Regulatory Manager
- Employment form
- Employment form: Full-time work
- Employment contract
- Employment contract: employment contract
- Employer type: Employer