Our Client - Mundipharma is one of the leading medium-sized pharmaceutical companies in Austria. As a modern pharmaceutical service company Mundipharma is developing highly effective medicines for use in pain management, oncology, opioid dependence and respiratory diseases, thus providing to improve the quality of life of affected patients. The Vienna subsidiary is acting as a Head Office for Central Eastern Europe region.
With a focus on Russia and Kazakhstan our client is looking for a highly competent and motivated professional, who will take a role of
Regulatory Affairs Manager
in Russia, Moscow
Regulatory Affairs will directly report to the Medical Director of Russia as well as having a close interface to the Head of Medical & RA/QA Manager AT & CEE, who is located in Vienna.
In this role, you will be responsible for support and implementation by assuring that marketing authorizations for all products are in compliance with applicable law and internal regulations.
Main Responsibilities and Tasks:
- Overall management of the entire Regulatory Affairs processes aligned to the national business priorities
- Effective review, completion and submission of applications for new registrations and variations
- Update of instruction for user (IFU) in compliance with the existing company core data sheet (CCDS)
- Planning, undertaking and overseeing importing of controlled drugs into Russia and Kz
- Update of dossiers according to EU- and non-EU regulations (CTD, ND)
- Proactive communication with external partners, e.g. local authorities, third parties, etc.
- Providing professional advice about regulations to manufactures, etc.
- Planning, undertaking and overseeing Regulatory Inspections
- Close interfacing with the Head of Medical & RA/QA AT & CEE in Vienna, where standards and guidelines are developed, established and monitored and/or with the Regulatory Affairs-Team on European level
To take a role in this challenging task you need to possess:
- University degree in life sciences (pharmacy, chemistry, biology, medicine) is a must;
postgraduate studies will be a plus
- 6-7 years experience in the area of regulatory affairs (preferable multinational company)
- Very good knowledge of the pharma and health care markets
- Experience in quality assurance of advantage
- Perfect knowledge of Russian Law and EU Drug Regulations
- Experience compiling and filing electronic CTD submissions in Russia
- High degree of accuracy and attention to detail
- Ability to work independently based on a hands-on mentality
- High flexibility and ability to work on a number of projects with tight timelines
- Very good and efficient communicator and able to cooperate with multiple departments
- Maintain confidentiality and security
- Business fluent English
- Very good IT skills
At Mundipharma we are proud to be among the best employers in different countries. Open communication and an appreciative approach shape everyday working life. The corporate culture is determined by social and entrepreneurial responsibility for employees and for the enterprise.