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Description

Job Description

Key Responsibilities
Act as a single point of contact for technical expertise in local laws, regulations, regulatory requirements and other regulatory related guidance in Research and Development and product registration of generic, new generic and new drugs in Thailand.
Ability to interpret regulations, technical guidelines, policies from the local Health Authority, translate into regulatory strategy, bringing innovative solutions and apply successfully in new MA applications and MA maintenance work.
Work closely with COREx and other cross-functional team to compile complete registration documents for faster product registration submission and approval in Thailand.
Prepare, monitor and identify issues early in the submission preparation process, assess the acceptability of submission, respond to regulatory authorities and update to internal stakeholders.
Provide regulatory input throughout the product life cycle, anticipate regulatory obstacles, propose strategies, monitor emerging issues and identify solutions and are involved in business/organization activities, management and strategy.
Negotiate and interact with regulatory authorities during the development and review process to ensure product registration submission and approval.
Provide guidance and coaching to develop local RA team members
Overview of submission compilation up to approval and launch

Knowledge, Skills And Abilities
Have strong technical and management skills and actively engage in regulatory strategy and operations.
Have regulatory knowledge throughout the product life cycle with aspects of effective management and strategy development.
Able to demonstrate skills and knowledge in areas such as, but not limited to: strategy development, risk assessment and management; monitoring and communicating regulatory and related changes.
Strongly and effectively communicating with international/multinational RA and relevant team such as quality, supply chain, procurement, etc.
Serves as a resource for best practices/quality on functional teams or project
Able to be a mentor for junior staff in technical skills including regulatory, product quality, pharmacovigilance perspectives.
Interprets internal or external business issues and recommends solutions/best practices
Able to work and leverage the strengths of cross-functional team.
Skilled at leading and managing people or projects

Qualifications
Minimum Bachelor

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