Responsibilities:

• Manages and evaluates the CMC dossiers of products in different dosage forms (tablets, capsules, suspensions, injection, solution, granules and powders) and pharmacological classifications.
• Proactively provides input on the current and upcoming New Regulation/Guideline and assess possible impact to registered/ upcoming registration product.
• Coordinate and liaise with necessary requirement for BE Study, CDP, BE site inspection, BE specific study.
• Create and submit routine monthly and annually report of imported product, selling product, product safety and product complain to TH-FDA
• Prepare a regulatory plan for submissions and renewals and ensure implementation as per agreed timelines.

Qualifications:

• Good communicator with consultative style, multi-tasting abilities and efficient co-ordination with cross functional team.
• At least 4 years professional experience in managing ethical pharmaceutical products (generics) regulatory / registration activities with Thailand FDA.
• Comprehensive knowledge on regulatory submissions such as Initial Product Registration, Product Registration Renewal, Variation application, Import /Distribution License and Company Registration under Health Authority.
• Preferably a License Pharmacist.