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A global pharmaceutical leader and the world’s largest generic medicines producer Teva Pharmaceutical is looking for a Regulatory Affairs Group Lead who will be leading Regulatory group of specialists and executing registration activities according to the Company strategy.
Core scope of responsibilities
Ensure new product registrations/line extensions according to company strategy (full cycle)
Maintain existing Marketing Authorizations in RU by ensuring timely submissions of variations/renewals
Communicate with Regional/Corporate team to ensure receipt of the relevant registration data and other materials for registration purpose
Strong understanding of the company’s needs and ability to keep targeted registration activity proper execution
Develop a plan on regulatory submissions according to general business strategy.
Make sure that all submissions done timely, according to the plan.
Leading team of RA specialists
Control the compliance of products to relevant legislation requirements and internal SOPs
Cross-functional cooperation with other department – QA/PV/Business where RA support required
Job experience and qualification
High Education (Biopharmaceuticals, Biochemistry, Chemistry, Pharmacy)
From 5 years relevant Experience in Regulatory Affairs, minimum 3 years of experience in RA managing position (leading teams) in a Western company within the Healthcare Industry
Comprehensive knowledge of Regulatory Affairs requirements
Advanced organizational, analytical, strategic skills with decision making capabilities
Excellence at communication and negotiation
Team-player
Advanced PC user
Advanced English.
