Leong Mee Chen

Experience

• 

  AA Pharmacy

  Oct 2014 - Nov 2015

  Locum Pharmacist

  1. Carry out stock inventory, checked and shelved new stock deliveries.2. Assist customers with medical purchases, advised on product selection for minor ailments.3. Ensure compliance of documentation for controlled items and maintain poison sales record.

• 

  Hospital Kuala Lumpur

  Oct 2014 - Nov 2015

  Hospital Pharmacist

  1. Undergo a year of provisionally registered pharmacist (PRP) training. 2. Competent in conducting essential roles of pharmacist in various pharmacy departments. Work in collaboration with other healthcare providers. 3. Coordinate the production of 2 Pharmacy Bulletin for Pharmacy Department. 4. Actively involved in talks, seminars or workshops.

• 

  Kementerian Kesihatan Malaysia

  Nov 2015 - Mar 2017

  Pharmacist

  1. Educate patients about the correct use and possible side effects of medication.2. Carry out medication therapy adherence clinic (MTAC) for diabetes mellitus patients by giving proper counseling and education to them.3. Lead pharmacist responsible for smoking cessation program in the clinic. 4. Reference point for healthcare professionals in the clinic in term of queries related to pharmacology, dosage, monitoring parameters and side effects of medicines.

• 

  Johnson & Johnson

  Apr 2017 - now

  1. Interact with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.2. Collaborate with management and internal stakeholders (eg. Medical Affairs, Marketing) to manage product strategy, local registration and launch activities. Align filing plans and timelines with internal stakeholders including management, business partners and regional office.3. Ensure compliance to J&J and local regulatory guidelines. 4. Provide ad-hoc local assessment on regulatory filings. 5. Ensure compliance to company SOP and Quality Management System.6. Provide guidance and leadership to the team. Show less 1. Develop and implement regulatory strategies to achieve rapid and high-quality approvals in order to achieve company’s business objectives. 2. Maintenance of existing product licenses to high standards. 3. Drive submission and approval of new products and line extensions in line with business expectations. 4. Contribute in project management to develop strategies, prioritize assignments, coordinate and implement regulatory actions in accordance with company objectives.5. Participate in industry-level regulatory events and maintain positive interactions with regulatory colleagues.6. Aid in building an effective regulatory team. Show less 1. Prepare and submit regulatory submissions with support from regulatory operations. 2. Maintain the local product files in line with current registered authorization details.3. Responsible for effective product lifecycle management to ensure license maintenance and supply continuity.4. Ensure positive interaction in any communication with the local health authority, in general and on product-specific topics. 5. Maintain up-to-date knowledge of local regulatory environments and communicate to key stakeholders. Contribute to compliance with all regulatory requirements. 6. Lead in charging for pharmacist Type A license, company import license, import permit applications of Dangerous Drugs (DD) or Psychotropics Drugs (PSY). Show less

  • Regulatory Affairs Associate Manager

    Nov 2021 - now

  • Senior Regulatory Affairs Specialist

    Mar 2019 - Oct 2021

  • Regulatory Affairs Specialist

    Apr 2017 - Feb 2019