REGULATORY AFFAIRS MANAGER
- Responsible for registration of products both under Pharmaceutical product, Medical Devices or others as related to Thai FDA and other government
- Maintain company’s licenses both import licenses and product licenses
- Ensure the variation submission and approval for the business continuity.
- Develops and implements strategies and tactics to expedite registrations, contributing to the earliest possible introduction of products and attainment
of corporate objectives.
- Responsible for all labeling development, promotional material approval and other Regulatory Affairs including the post-marketing requirement.
- Provide the guidance to relevant associates for the promotional material approval.
- Provide regulatory support of marketed products.
- Works with the Industry Association for the new regulations.
- Ensure the company comply to related act e.g. pharmacovigilance, Safety Monitoring Program.
- Ensure the company have all mandatory reports.
- Communicate with Regional and Global to get the right dossiers, prepare and submit registrations dossiers according to updated requirements e.g.
ICH, ACTD and CSDT.
- Present registration dossiers to relevant government agency, discuss scientific issues and enhance/ expedite the progress of approval.
- Escalate and follow the updated procedures of Regional or Global to get the proper approval of new projects.
- Work with cross functional associates e.g. Supply chain and Marketing to ensure the goods clearance at the port.
- Manage all systems for data base to maintain records of all registration activities, artworks labeling and promotional material approval.
- Provide the report of new regulations and the business impact .
- Maintain and create the good relationship with Thai FDA authorities.
- Prepare the local SOP to align with the company direction.
- Degree in Pharmaceutical Sciences or related field and Master degree in management or sciences
- 6 years’ experience in Regulatory Affairs
- 8 years’ experience in Regulatory Affairs with at least 3 years’ experience in MNC of medical devices and pharmaceutical industry.
- Thorough knowledge of regulatory requirements at least for medical devices and pharmaceutical products.
- Understand the unique requirement of Contact Lens Care.
- Good government relations especially Thai FDA for both Drug bureau and Medical Devices Control Division
- Managerial skills , Good communication skill, Interpersonal skill, learning agility
All interested applicants are most welcome by sending the application with attached full resume in English indicating qualifications and experience, current
salary, expected salary and recent photo to given.
Please send CV to
Kensington Associates Recruitment (Thailand) Ltd.
Unit 4/1, 4th Floor, Bangkok Union Insurance Bldg 1
75-177 Surawongse Rd, Bangrak, Bangkok 10500
Tel: 02 634 8884-6 Fax: 02 634 8883