Our client is a company that was founded in the USA and is one of the world’s leading providers of health care products and medical devices. The company is currently seeking for a suitably qualified candidate to fill the position of Regulatory Affairs Manager.
- Driving reduction of registration cycle time through Speed to Market initiatives.
- Working closely with Global RA team to obtain complete registration documents for faster product registrations in Thailand.
- Understanding and influencing Thailand regulatory environment by leveraging key relationships with industry groups.
- Defining and implementing regulatory strategies and plans for 3 Business Units in Thailand.
- Assisting Commercial team on product artwork and labelling compliance.
- Supporting Regional QA in the development and implementation of Quality Systems in Thailand.
- Providing leadership for interpretation; providing support and advice to the parties involved (employees, customers, distributors, suppliers, etc.) to understand and follow the SOPs in accordance with Corporate Quality Policy.
- Providing training to Thailand employees in all RA & QA related subjects.
- Managing Pharmacovigilance, product compliance, non-compliant products and processes in collaboration with Global RA, Global QA and commercial teams.
- Managing people, budget and resources of Regulatory Affairs.
- Supporting Regional QA to ensure that company and distributor warehouses meet global standards.
- Focusing on new product registration and paper work.
- Male or female, aged at least 30 years old.
- Bachelor’s degree in Pharmacy.
- Must be familiar with Regulatory environment and have an understanding of labelling regulations and controls.
- At least 5 years of experience in regulatory affairs and product registration management.
- Must be able to interact with internal Client teams and manufacturing site personnel in a professional manner.
- QA knowledge and experience is an asset.
- Solid work experience with Multi-National Companies with Pharmaceutical experience.
Qualified candidates please submit your resumes stating present and expected salary & package details via APPLY NOW