About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
The Supervisor, Regulatory Affairs will be responsible for organizing of Registration and Certification activities primarily in Russia and some in CIS. The incumbent will work in Russian Logistics department to establish and maintain appropriate systems to ensure Regulatory Compliance consistent with applicable state, federal and international laws.
- Drive Regulatory Affairs function, by managing processes and reporters.
- Subject matter expert on various regulations as well as coordinate issue resolution through the use of outside consultants, regulatory agencies, and / or internal resources.
- Organizes work on the registration of all company products in Roszdravnadzor.
- Organizes work to obtain the required permit documentation in the certification bodies.
- Prepare product regulatory submissions and assist in activities to support the approved products during their lifecycle.
- Arrange to obtain necessary for the registration of documents from the manufacturer.
- Organizes the required trials.Controls and monitors process of registration and certification processes
- Participate in Project Teams and New Product Introduction Teams to support product launch.
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- Prepare regulatory submissions for authorities in other countries as required
REQUIREMENTS / EDUCATION:
- Required language skills: proficient in English (oral and written);
- Must have a minimum of 3 to 5 years of registration and certification work experience, Experience in Certification bodies is a plus.
- Knowledge of regional requirements of local registration and certification laws of Russia and other countries as applicable.
- Knowledge of regional Import/Export regulations.
- Direct and positive experience in communicating with Regulatory Authorities.
- Multi-site experience, in a large sized company.
- Requires the ability to provide solutions based on their own knowledge and industry experience base. Some travel is required.
- Requires ability effectively manage document flows.
- A minimum Master degree is requires. Law degree is a plus.