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Regulatory Affairs Group Lead Belarus Minsk

Minsk
2021-05-30 02:43:31
Regulatory Affairs Group Lead Belarus Minsk
Position title: Regulatory Affairs Group Lead Belarus

Reporting line: Regulatory Affairs Head

Location: Minsk office

Primary Purpose of the position: 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 Belarus 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/SC/Business where RA support required

Requirements:
• 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
• Open-minded, self-motivated person
• Team-player
• Advanced PC user
• Advanced English
•
Minsk Belarus
Regulatory Affairs Group Lead Belarus Minsk Kelly Minsk
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Aici gasesti europaleti! Bucuresti DE RO
Aici gasesti europaleti!
Bucuresti DE RO

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