Senior Regulatory Affairs Executive

Mô tả Công việc
Regulatory and Compliance Duties
· 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&039; requirements.
· 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.
· To provide timely progress reports and budgeting information to Senior Manager, QRA.
· Liaise with principals, local regulatory authorities and internal stakeholders on new product registrations, post registration maintenance and post market surveillance.
· Manage the overall cost and budget for business licenses and certifications and new product registration and amendments.
· Oversee and track RA&039;s team overall performance on business certifications and license applications and maintenance, product registrations&039; progress and maintenance.
· Perform business permit and licenses application and conduct maintenance including renewals and amendments.
Quality Assurance including Internal Process, Standardisation, and Improvement
· Led the QRA team and internal stakeholders in Goods Storage Practice (GSP) and Goods Distribution Practice (GDP) certification, ensuring process and documentation compliance.
· 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.
· Manage and conduct customer and supplier audits and follow up till audit closure.
· Oversee the development, review and update of company&039;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&039;s QMS requirements.
Pharmacovigilance and Training
· Conduct Pharmacovigilance (PV) training, PV literature screening and provide relevant updates to stakeholders where applicable.
· Act as National Responsible Person for Pharmacovigilance (NRPP) as required per local PV legislation.
Other responsibilities
· Carry out any other duties assigned from time to time by Senior Manager, QRA.

Yêu Cầu Công Việc
Qualifications and Requirements:
· Able to understand and convey technical information to principal and other stakeholders.
· Radiation Worker Certificate is a plus.
· Able to communicate fluently in both written and verbal English.
· Familiar with regulatory registration process and requirements for Medical Devices, Pharmaceuticals, Poison Drugs etc.
· 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.
· Bachelor degree in Pharmacy (Pharmacy Practice Certificate to include importation and exportation scope)
· 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 under pressure and tight timelines.
. Able to work in Ho Chi Minh City

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Cập nhật gần nhất lúc: 2024-08-22 12:40:03