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  • Regulatory Affairs Manager Almaty
  • TEVA in Almaty, , Kazakhstan
  • jobs
  • 1 month ago

jobs description

Компания "TEVA"

Reporting to: Regulatory Affairs Team Kazakhstan

Position Purpose:

Regulatory Affairs Manager Kazakhstan is responsible for implementation of functional activities for registration, registration renewal, amendments to the registration dossier and harmonization as per EAEU requirements for medicinal products produced by Teva manufacturing sites and contractors, as well as other functional activities to ensure maintenance of the products lifecycle, as well as ensuring compliance with serialization requirements in the Republic of Kazakhstan (layouts, national catalog, etc.)

Responsibilities:
• implements regulatory strategy for ongoing and future projects, regulatory work plans
• adjusts regulatory work plan as per changes in local requirements and business needs
• provides timely expert assessment of registration dossiers as per business requests
• monitors and updates key stakeholders on updates in local and Eurasian pathway requirements
• Serialization support
•... ensures efficient collaboration with Medical, Pharmacovigilance, Business Development, Supply Chain, Marketing, Legal and other departments
• ensures efficient communication with manufacturing sites
• ensures regular reporting to headquarters and local management as per business requests
• communicates with government agencies
• represents the company in the association of international pharmaceutical manufacturers (AIPM)
• efficiently analyzes large amounts of data in limited timeframe

Requirements:

Education & Experience:
• a degree in Medicine, Chemistry, Biology, Biochemistry, Biotechnology, Pharmaceutics
• at least 3 years of work experience in Regulatory Affairs
• advanced PC user (MS Office or equivalent)
• oral and written business English proficiency (at least intermediate)

Required Skills/Abilities:
• extensive knowledge of applicable government regulations
• ability to convey updates and educate peers, managers and department heads on regulatory requirements
• excellent written and verbal communication skills
• excellent analytical and problem-solving skills
• regulatory database and compliance software proficiency
• attention to detail
• clear understanding of product lifecycle from R&D to successful launch

Leadership and functional competencies:
• result oriented
• critical, operational, and strategic thinking
• keen to improve and strengthen existing processes
• effective time management skills, including working with multiple projects simultaneously
• proactive problem solving
• business oriented
• efficient communication and cross-functional collaboration
• leadership and project management
Almaty Kazakhstan

salary-criteria

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