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The incumbent will collaborate closely with the Regulatory Affairs Manager and key stakeholders across Malaysia and Brunei to drive the successful delivery of the business objectives. The incumbent's expertise will be crucial in obtaining timely approvals for new products and renewals while ensuring strict adherence to regulatory compliance.
In this role, you will be a pivotal person in providing essential regulatory management for animal health products. Your responsibilities encompass formulating strategies and overseeing regulatory submissions & adherence for all products within the region. You will also be the company's representative.
The incumbent will be managing the team to ensure regulatory and quality assurance activities throughout the product lifecycle ranging from Pre-Market Medical Device Registration, Change Notification, Special Authorisations/Exemptions, and Post-Market Surveillance in collaboration with the relevant government bodies in Malaysia, Singapore and Indonesia.
The team lead will be ensuring compliance with regulatory requirements governing renal healthcare services. Responsibilities include developing and implementing regulatory strategies, policies and procedures to maintain adherence to local and international standards. This person will also oversee the preparation and submission of documents and applications including licenses and certifications while collaborating with cross functional departments.
Are you passionate about Regulatory Affairs and driven to make an impact in the pharmaceutical industry? This RA Manager will work closely with the CEO and key stakeholders in Southeast Asia to ensure successful regulatory objectives. Your expertise will be crucial in overseeing regulatory projects.
The Pharmacovigilance Specialist will be the deputy Local Responsible Person for Pharmacovigilance (LPPV) on behalf of the company for regional country, mainly China. This includes ensuring compliance with the regulations set forth by the National Medical Products Administrations (NMPA) and the National Pharmaceutical Regulatory Agency (NPRA) and overseeing all pharmacovigilance (PV) activities.
The Clinical Trainer is essential for helping health care professionals (HCPs) grasp vital clinical concepts in a clinical setting. They offer personalised one-on-one training to address the specific educational requirements of HCPs, including topics like anatomy, ageing, aseptic non-touch technique (ANTT), and the application of injection techniques from the Aesthetic Curriculum.
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