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Role Summary:
Under limited supervision responsible for the local implementation of regulatory and quality activities and strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of drugs, biologics and medical devices products.
Area of Responsibility (AOR) for Role:
• Strong experience in drugs and biologics
• Relevant experience in medical devices in Malaysia
• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements.
• Represent or lead Regulatory Affairs in small project teams
• Provide guidance to junior team members when needed
• Perform other duties as assigned
Work Qualitication/Experience:
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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Job details are sourced from the employer's original posting.
Open job postingAbout the company
Baxter Healthcare (M) Sdn Bhd is a subsidiary of Baxter International, a global healthcare company that develops, manufactures, and markets products to treat kidney disease, diabetes, and other chronic and acute medical conditions.