Open to opportunities

Hsu Mon Htet

@hsumonhtet

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Experienced regulatory affairs manager with a strong pharmacy background.

Myanmar

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What I'm looking for

I am looking for a role that challenges my regulatory expertise and fosters professional growth.

I am a dedicated Regulatory Affairs Manager with over 10 years of experience in the pharmaceutical industry. My journey began as a Medical Representative, where I developed strong relationships with healthcare professionals and gained valuable insights into market dynamics. This foundation paved the way for my roles at the FDA, where I honed my skills in regulatory compliance and quality assurance.

Throughout my career, I have successfully managed drug registrations, ensuring compliance with Myanmar FDA regulations. My experience includes overseeing the registration of drugs, food supplements, and medical devices, as well as conducting inspections to uphold Good Pharmacy Practices. I pride myself on my ability to communicate effectively with suppliers and government officials, ensuring that all processes run smoothly and efficiently.

Currently, I am seeking new challenges that will allow me to leverage my expertise in regulatory affairs while contributing to a dynamic team. I am passionate about ensuring the safety and efficacy of pharmaceutical products and am committed to continuous professional development in this ever-evolving field.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Manager

Eco Asia Co., Ltd

Aug 2023 - Present (1 year 11 months)

Responsible for the registration of various products including drugs, food stuffs, food supplements, cosmetics, and medical devices with MMFDA. Ensured efficient communication with suppliers and government officials to maintain regulatory compliance.

Regulatory Affairs Compliance document preparation Supplier Communication Government Relations Online Dossier Submission Regulatory Strategy Quality Assurance

Regulatory Affairs Manager

Mahar Loka Co., Ltd.

Mar 2020 - Present (5 years 4 months)

Oversaw the registration of drugs, food stuffs, food supplements, cosmetics, and medical devices in MMFDA. Communicated and provided advice on rules, regulations, and labeling guidelines to clients and suppliers.

Regulatory Affairs Compliance Document Management Client Communication Supplier Communication Online Submission

Regulatory Affairs Executive

Right & Bright Int'l Co., Ltd.

Oct 2018 - Present (6 years 9 months)

Managed the registration of drugs, food stuffs, food supplements, cosmetics, and medical devices with MMFDA. Requested necessary and unmatched documents from suppliers and handled DIAC application processes.

Regulatory Affairs document preparation Compliance Supplier Communication Online Dossier Submission

Inspector Pharmacist

FDA, Pyay District

Jan 2017 - Present (8 years 6 months)

Conducted post-marketing surveillance and inspected drug shops and medical companies for adherence to Good Pharmacy Practice and National Drug Law. Reported monthly to Bago Division FDA and collaborated with NGOs for post-market surveys.

Regulatory Compliance Reporting Advocacy Communication National Drug Law

Regulatory Pharmacist

FDA, Naypyitaw

May 2014 - Present (11 years 2 months)

Checked submitted samples for compliance with standards, including labeling, appearance, batch, manufacturing, and expiration dates, against COA. Managed DIAC process documents for new and renewal applications, including related addendum lists.

Regulatory Compliance Document Management Quality Control Communication Data Verification Standard Operating Procedures Regulatory Affairs

Medical Representative

Ni Lay Naing Co., Ltd.

Mar 2013 - Present (12 years 4 months)

Visited government and private hospitals, GPs, and pharmacies to share new product knowledge and awareness. Collaborated with the distributor team to ensure storage, stock availability, and supply processes.

Sales Product Knowledge Market Research Budget Management Reporting Communication Scheduling

Education

Degrees, certifications, and relevant coursework

University of Pharmacy, Yangon

Bachelor of Pharmacy, Pharmacy

Completed a Bachelor of Pharmacy degree from the University of Pharmacy, Yangon. The curriculum provided a comprehensive understanding of pharmaceutical sciences and practices.