Senior Regulatory Affairs Executive

Regulatory and Compliance Duties
· Handle regulatory enquiries and issues relating to the sales and distribution of regulated products including customer complaints, adverse events etc and follow up to closure.
· Perform product registration, renewals and amendments for all new and existing products including Medical Devices, Radioactive Products, Pharmaceuticals, Poison Drugs etc. and ensure compliance to regulatory authorities’ requirements.
· Oversee and track RA’s team overall performance on business certifications and license applications and maintenance, product registrations’ progress and maintenance.
· Liaise with principals, local regulatory authorities and internal stakeholders on new product registrations, post registration maintenance and post market surveillance.
· Perform business permit and licenses application and conduct maintenance including renewals and amendments.
· To provide timely progress reports and budgeting information to Senior Manager, QRA.
· Manage the overall cost and budget for business licenses and certifications and new product registration and amendments.
Quality Assurance including Internal Process, Standardisation, and Improvement
· Lead review of current processes such as product registration process with inter- department stakeholders and implement QRA continuous improvement projects to achieve harmonisation and standardisation.
· Led the QRA team and internal stakeholders in Goods Storage Practice (GSP) and Goods Distribution Practice (GDP) certification, ensuring process and documentation compliance.
· Oversee the development, review and update of company’s manuals and procedures including System Procedures, SOPs as per applicable international and local regulations and standards such as GSP and GDP, adhering to company’s QMS requirements.
· Manage and conduct customer and supplier audits and follow up till audit closure.
Pharmacovigilance and Training
· Act as National Responsible Person for Pharmacovigilance (NRPP) as required per local PV legislation.
· Conduct Pharmacovigilance (PV) training, PV literature screening and provide relevant updates to stakeholders where applicable.
Other responsibilities
· Carry out any other duties assigned from time to time by Senior Manager, QRA.

Qualifications and Requirements:
· Able to understand and convey technical information to principal and other stakeholders.
· Able to work under pressure and tight timelines.
· Radiation Worker Certificate is a plus.
· Able to communicate fluently in both written and verbal English.
· Bachelor degree in Pharmacy (Pharmacy Practice Certificate to include importation and exportation scope)
· Familiar with regulatory registration process and requirements for Medical Devices, Pharmaceuticals, Poison Drugs etc.
· Minimum 3 years of working experience as a pharmacist and/or with proven regulatory and compliance specialisation experience in Medical Device/ Pharmaceutical or equivalent industry.
· Able to work both independently and in a team environment.
· Strong leadership skills with advanced communication and interpersonal skills including critical thinking and problem- solving.

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Cập nhật gần nhất lúc: 2024-04-03 11:36:23