Regulatory Affairs Specialist
In a large foreign company open position of Regulatory Affairs Specialist (veterinary medicines)
Responsibilities:
- To review and assess regulatory documentation prepared by global regulatory department for further submissions to local Regulatory Authorities;
- Own interactions with Competent Authorities at all steps of product registration process, prepare dossier documents, arrange translation, complete registration dossiers for new products submissions in accordance with yearly registration plan, to ensure in-time receiving of approval documents;
- To arrange payment of local regulatory fees, to ensure import permits obtaining for registrations samples delivery;
- To ensure declaration on conformity getting when applicable;
- To identify potential risks and gaps in the assigned projects and propose solutions to mitigate those;
- Accountable for providing the most accurate and up-dated information about regulatory requirements in geography of responsibility in respond to any intra-company internal request;
- Deliver projects in time, whilst ensuring communication of status and requirements across multiple business functions, organize and hold regular calls and F2F meetings with involved function areas;
- To provide support with arrangements for GMP inspections of manufacturing sites by Russian;
- Communication of submissions via regional and global teams through regular up-date of global regulatory databases and trackers;
- Ensure regulatory compliance of printed packaging materials (review label artworks in the system, preparing regulatory compliant text for artworks, approving in system in accordance with company process);
- Prepare responses to official requests received from the Local Regulatory authorities;
- To review and ensure compliance of local promotional materials;
- Understand and act according to regulatory compliance and local policies, track and follow-up on any changes in regulatory requirements of CIS/RU;
- Ensure compliance with procedures and systems necessary to maintain proper regulatory records;
- Support other departments with RA information/communication.
Requirements:
- University degree in pharmaceutical or medical sciences, with veterinary study preferred;
- English language - upper-intermediate;
- Good knowledge and understanding of local legislation in regulatory sphere;
- Experience of working in Regulatory Affairs - at least 2 years.
Benefits:
- Fixed salary (based on interview results);
- Annual bonus;
- Competitive salary and bonus system;
- Medical and life insurance.