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Condition: Contractor

MAJOR TASKS AND RESPONSIBILITIES:

Contribute to routine regulatory activities for portfolio assigned, such as
- Dossier assembly, review, production and submission
- Timely request of Registration samples where needed
- Review and optimize labelling in close alignment with global labelling group and meeting corporate labelling standards
- Artwork preparation and mock-up submission
- Ensure regulatory compliance for life cycle management including evaluation and implementation of manufacturing and labelling changes in accordance with local regulations and relevant Bayer SOP

Support in the submission or perform actual submission of drug (New Chemical Entities (NCE), new indications, new presentations, new manufacturing site and variations) including food, cosmetics, medical devices and other products and follow through from submission to approval with close supervision from RA Manager.
Prepare, submit and follow up the approval of promotional material applications from Thai FDA
Maintain global regulatory databases accordingly. Provides support in product archiving: approvals documentation, correspondences filing and local dossier archive (according to direction of superior).
Assists RA Manager for regulatory submission and approval oversight and manages regulatory databases including any regulatory tools or systems for Myanmar, Cambodia and Laos. Reviews artworks and labeling for Myanmar, Cambodia and Laos.
Performs other duties required by superior from time to time
Where applicable, may be involved in other regulatory projects from local and regional Regulatory Affairs from time to time with close and direct supervision from RA Manager.