Regulatory Affairs Team Lead Kazakhstan
Teva Pharmaceuticals
Job location
Almaty
Employment status
Full–time
Job details
Who are we?
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growthJob Description
Regulatory Affairs Team Lead 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:
• Develops regulatory strategy for ongoing and future projects
• Oversees execution of regulatory work plans
• Prepares and oversees regulatory annual budget as per approved work plan
• Adjusts regulatory work plan as per changes in local requirements and business needs
• Oversees structure and staffing of regulatory department
• Provides timely expert assessment of registration dossiers as per business requests
• Monitors and updates key stakeholders on updates in local and Eurasian pathway requirements
• 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
• Efficient supervision of direct reports
• Communicates with government agencies
• Represents the company in the association of international pharmaceutical manufacturers (AIPM)
• Efficiently analyzes large amounts of data in limited timeframe
Qualifications
Education & Experience:
• a degree in Medicine, Chemistry, Biology, Biochemistry, Biotechnology, Pharmaceutics
• at least 5 years of work experience in Regulatory Affairs (managerial experience is highly desirable)
• advanced PC user (MS Office or equivalent)
• oral and written business English proficiency (at least upper 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 analytical and problem-solving skills
• excellent strategic planning skills
• regulatory database and compliance software proficiency
• experience in managing a team
• clear understanding of product lifecycle from R&D to successful launch
• critical, operational, and strategic thinking
• keen to improve and strengthen existing processes
• proactive problem solving
• efficient communication and cross-functional collaboration
• leadership and project management
Function
Regulatory AffairsSub Function
Medical Regulatory AffairsReports To
In process of validationAlready Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws
