Regulatory affairs manager
Spring Professional Recruitment (Thailand) Limited
jobsDB ref: JTH300003001212186
Regulatory Affairs Manager
Main duties and responsibilities:
Be a Regulatory Affairs business partner to provide timely, value-added, strategically regulatory support to the business in Thailand : pharmaceutical , OTC and medical devices
- Be a RA business partner to provide timely, value-added, strategically regulatory support to the local business in Thailand
o Provide regulatory advices and inputs to various functions e.g. marketing, technical, sales, business development etc.
o To ensure regulatory compliance to all local regulations, providing risk assessments and offering innovative regulatory options for the business partners
o Actively involved in issue management for mitigate business impacts
- Responsible for all regulatory professional or related work in Thailand:
o To manage & coordinate with the assistance of local RA staff on all local registration submissions, variations and approvals including new product applications, switches, renewals, advertisements, packaging & labels changes.
o To manage and coordinate all issues and queries related to health authorities or agencies related to regulatory work.
o To assist in reviewing formulations and claims related to regulations of local products.
o Responsible to maintain good local regulatory documentation system including updating of regional regulatory databases.
o To manage and coordinate the planning and execution of registration dossier submission, monitoring progress, status & timelines.
o To handle & resolve any local emerging regulatory problems & issues.
o To anticipate in regulatory influencing activities and monitoring of regulatory trends & environment, to assess the impact on local business and providing options to respond to issues.
o Any other regulatory or related work/ projects as assigned e.g. Pharmacovigilance.
- To assist & support any regional RA initiatives, projects and work as assigned either as a lead or a team member
- Bachelor’s Degree in Pharmacy
- Minimum 5 years experience in regulatory works in the managerial level
- Good interpersonal, strategically thinking and effective communication skills
- Analytical, attention to detail and problem-solving skills
- Knowledge of FDA regulations and standards
- Good command in spoken and written English
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About Spring Professional Recruitment (Thailand) Limited
Spring Professional is an international firm specialising in information technology, engineering and property & construction recruitment across the Asia region.
We bring great people to great organisations, with our focus being exclusively on the recruitment of middle to senior level management and specialists.
We develop trusted relationships with our partners, sharing market intelligence and recruitment advice to help you understand and respond to Asia’s ever-changing and fast paced labour markets.
Whether you’re a company looking for full-time or contract team members or an individual looking to make the next career move, the team at Spring will work with you to provide a seamless and high value service ensuring that your expectations are fully managed at all stages of the process.
Spring Professional is a wholly-owned subsidiary of Adecco, the world’s largest human resource solutions organisation, headquartered in Zurich, Switzerland
With more than 20 years' experience, we globally place over 12,000 people annually into contract, temporary and full-time positions.