Teva Senior Regulatory Affairs Associate 

Thailand, Bangkok, Bangkok 

275189956

Teva Pharmaceuticals is currently in need of a dynamic and highly motivated Senior Regulatory Affairs Associate.

• Coordinate with global regulatory teams and local health authorities on pre-dossier procedures, product dossier registration submission and approvals including all variations
• Provide regulatory and technical perspectives to regulatory team and other departments on product registration, submission, approval and all variations
• Understand regulations, technical guidelines, and policies from the local health authorities and update regulatory team on regulations, guidelines, and procedures
• Work with regulatory team and other functions to create solutions and implement agreed mitigation plans
• Provide regulatory input throughout the product life cycle of responsible product lines and understand or raise regulatory obstacles to Head of regulatory Function
• Work closely with local health authorities throughout the product life cycle of responsible product lines, provide documents as authorities’ requests within regulated timeframe, submit required reports regulated by the authorities within regulated timeframe, anticipate any risk & impacts of regulatory matters and inform Head of Regulatory Function
• Supervise junior regulatory staff

• Bachelor’s degree in Pharmacy
• 5 years of experience with generic, new generic and/or new drugs registration
• Experience of working with Multi-national companies in Pharmaceuticals
• Have good knowledge of Thailand regulatory authorities, laws, regulation, requirements and guidelines
• Understand technical point of view including product development, bioequivalence, product quality, safety and efficacy
• Proficiency in written and spoken Thai and English languages
• Good interpersonal and negotiation skills

Senior Regulatory Affairs Manager

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