Our Client, original western pharmaceutical company declares the vacancy of Regulatory Affairs manager.
- Provide registration/re-registration of the Company's products in Russia
- Prepare documentation for registration/re-registration of medicines
- Submit application for registration
- Provide regulatory expertise within the organization, ensuring total compliance with legal requirements and ethical norms;
- Provide validation support and technical advice to the medical, marketing and sales teams; anticipate problems and actively seek alternatives and be proactive in proposing solutions;
- Development effective relations with appropriate government officials involved in the registration and validation process
- Receive registration certificates.
- Education: Pharmacy, chemistry, PhD is desirable
- Relevant experience in Regulatory Affairs sphere in Pharmaceutical company: min 5 years
- English -upper intermediate
- Established good relationship with HA and pharmaceutical networks
- Understanding of local regulations/guidelines concerning drug regulatory affairs
- Highly advanced organizational, analytical, strategic skills with decision making abilities
- Company offers competitive salary,social package.