Category

Description

• Lead country RA team for new product registrations, license extensions, variations, renewals per agreed timeline, and ensure approvals in a timely manner for entire Baxter Malaysia portfolio – inclusive of drugs and devices
• Develop and execute regulatory plans for new products and maintenance of licences/authorizations per country business needs thereby ensuring regulatory compliance for distributed products e.g. in terms of licenses, permits, GMP clearances, labeling, promotional materials etc.
• Engage with Health Authority – Both BPFK and MDA for Baxter projects as required and strengthen Baxter’s reputation as an ethical, responsible and scientifically sound company.
• Compile regulatory documents for submission per local requirements -Review, edit and proofread regulatory documentation
• Track status and progress of regulatory documentation
• Assist in preparation, review and training if necessary of labelling, SOPs, and other departmental documents
• Monitor applicable regulatory requirements; assure compliance with the company’s and external standards
• Compile and prepare responses to regulatory authorities’ questions and Support the local manufacturing facility where necessary
• Maintain regulatory files in a format consistent with requirements
• Establish communication and good working relationships within RA, other functions and the health authorities
• Maintain awareness of regulatory requirements and Participate as an active team member of regional project teams as required

• Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with 7-8 years regulatory experience in a pharmaceutical and medical device regulatory affairs role and leadership experience preferred.
• Pharmacist license is a MUST
• Strong verbal and written communication and presentation skills
• Knowledge of applicable regulatory laws & acts and well versed with changing scope and evolving regulations both for drugs and devices
• Ability to independently identify compliance risks and escalate when necessary
• Ability to collaborate with different functions to effect change, including Quality Assurance, Clinical Operations, Supply Chain and Logistics, Manufacturing, Marketing, Sales and other business development entities in the organization
• Good verbal and written communication skills for effective communications and negotiations with both internal and external stakeholders.
• Ability to manage complex projects and timelines in a matrix team environment with multitasking and prioritization
• Proficiency in Microsoft office including Word, PowerPoint and Excel, spreadsheets, databases, and online research
• Proofreading and editing skills

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