Regulatory Affairs Specialist (Pharma/ Medical Device, Food Science, Chem)
• Monitor emerging regulatory trends and integrate new requirements into department procedures and toolkits.
• Provide regulatory support to currently marketed products, as necessary.
• Assess product and manufacturing changes for compliance with applicable regulations and prepare submissions and reports as required by classification and geography.
• Provide regulatory support to product manufacturing transfers.
• Provide regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes.
• Provide statistical support and bridging between Clinical and Data Management/Biostatistics team members. I
• mplement regulatory aspects of Field Actions.
• Provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis.
• Provide regulatory input to the company for compliance with Global, Regional, and HSA Quality System Regulation requirements.
• Provide input for clinical studies to assure compliance with domestic and international regulatory requirements (GCP), as well as to ensure efficient and approvable study designs
• Assist in negotiations with the HSA or other regulatory agencies for assigned projects.
• Obtain and distribute updated information regarding worldwide laws, guidelines, and standards.
• Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities.
• Develop and deliver presentations to worldwide regulatory agencies.
• Topics may include submission strategies, technical and statistical approaches, compliance issues or new initiatives.
• Assist in developing and maintaining positive relationships with device reviewers through oral and written communications.
• Other tasks, as assigned.
EDUCATION AND EXPERIENCE
• Min Degree in any science related field
• Minimum 2 - 3 years of experience in either domestic and regional regulatory affairs would have an advantage
• Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage
• Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Regulatory Affairs - Leon)
Leon Leong De Cong
EA License: 99C4599
Recruit Express Pte Ltd
Recruit Express Pte Ltd