Sabai Phyu Sin
Queens,NY
Summary
- Hardworking and passionate job seeker with strong organizational skills eager to secure full time position in the United States. Ready to help team achieve company goals.
- Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
9
9
years of professional experience
Work History
Regulatory Affairs Manager
Eco Asia Company Limited
04.2022 - 10.2023
- Worked with governance committees to make and evaluate plans.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Prepared and maintained document inventory for core dossier preparation.
- Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
- Provided expert guidance on global regulations, leading to successful market entry of new products.
Senior Regulatory Affairs Specialist
Medtronic Company Limited
01.2021 - 04.2022
- Prepared and submitted regulatory file applications and supporting documentation.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Ensured successful product launches by navigating complex regulatory requirements and obtaining necessary approvals in a timely manner.
- Enhanced company compliance with FDA regulations by conducting thorough internal audits and implementing corrective actions.
- Maintained and archived regulatory paperwork.
- Prioritized project-related tasks to efficiently complete essential tasks.
Regulatory Affairs Specialist
Mundipharma Company Limited
01.2019 - 01.2021
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Prepared and submitted regulatory file applications and supporting documentation.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Maintained and archived regulatory paperwork.
- Prepared and maintained document inventory for core dossier preparation.
- Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.
Product Executive
Mundipharma Company Limited
01.2019 - 01.2021
- Collaborated cross-functionally with engineering, design, and sales teams to ensure seamless product launches.
- Determined product pricing by conducting research into market data.
- Increased customer retention rates through continuous improvements to existing products based on user feedback and analysis of usage patterns.
- Strengthened relationships with key clients through proactive communication and understanding their needs, leading to long-term partnerships.
Regulatory Affairs Associate
Sea Lion Company Limited
12.2016 - 12.2018
- Prepared and maintained document inventory for core dossier preparation.
- Streamlined regulatory processes for increased efficiency in submitting drug applications to the FDA.
- Assisted in developing effective strategies for addressing FDA inquiries, leading to faster resolution times.
- Maintained open lines of communication with FDA representatives throughout submissions processes, fostering positive relationships that contributed to expedited approvals.
- Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
Quality Control Supervisor
Fame Pharmaceutical Industry
12.2014 - 12.2016
- Writing and Reviewing Standard Operating Procedures(SOP)
- Calibrating analytical equipment, as and when required
- Ensuring that procedures are carried out carefully and accurately to eliminate errors
- Investigate customer complaints and non-conformance issues by cooperating together
- Cooperate with logistics staff to ensure timely and safe delivery of goods and services
- Timely reporting by usage of intranet computing systems for internal and external ISO audits
Junior Pharmacist (Part Time)
Asia Royal Hospital
12.2014 - 12.2015
- To provide medicine to patients as per prescription of Specialist and Physician and explain the patients how to take medicine in a right way.
- Contributed to a positive work environment by collaborating effectively with senior pharmacists and support staff.
- Enhanced pharmacy efficiency by assisting with inventory management
- Educated patients on proper medication administration techniques, ensuring safe and effective use.
Education
Master of Public Health -
University of New Haven
West Haven, CTBachelor of Pharmacy - Pharmacy
University of Pharmacy
Yangon, Myanmar03.2014
Skills
- Regulatory Submissions
- Global Regulatory Compliance
- Document Management
- Pharmaceutical Industry
- Time Management
- Team Collaboration
- Active Listening
Timeline
Regulatory Affairs Manager
Eco Asia Company Limited
04.2022 - 10.2023
Senior Regulatory Affairs Specialist
Medtronic Company Limited
01.2021 - 04.2022
Regulatory Affairs Specialist
Mundipharma Company Limited
01.2019 - 01.2021
Product Executive
Mundipharma Company Limited
01.2019 - 01.2021
Regulatory Affairs Associate
Sea Lion Company Limited
12.2016 - 12.2018
Quality Control Supervisor
Fame Pharmaceutical Industry
12.2014 - 12.2016
Junior Pharmacist (Part Time)
Asia Royal Hospital
12.2014 - 12.2015
Master of Public Health -
University of New Haven
Bachelor of Pharmacy - Pharmacy
University of Pharmacy
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