全职 Senior RA Specialist 工作, 薪水, Abbott Laboratories Central Region (Singapore) 公司招聘中 - Ricebowl

Primary Function:

• Provide support for the regulatory department to ensure efficient and compliant business processes and environment
• Execute regulatory tasks and exercise influence generally at the middle management level
• Maintain current registrations by preparing documentation required and submitting documentation on schedule as directed

Key Responsibilities:

• Ensures timely approval of Nutritional products, functional foods & drugs for assigned region/countries.
• Directing development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc
• Provide regulatory input to product lifecycle planning
• Assist in the development of regulatory strategy and update strategy based upon regulatory changes
• Interpret and apply regulatory requirements
• Understand, investigate and evaluate regulatory history/background of product context in order to assess regulatory implications for approval
• Participate in risk-benefit analysis for regulatory compliance
• Plan and organize non-routine tasks with approval; initiate and/or maintain work schedule
• Maintain regulatory data in electronic systems
• Be involved in various regulatory activities (review of product documentation; regulatory submissions and follow-up; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings and patent information; review and approval of label changes, advertising and promotional items; provide regulatory input to product safety issues and product recalls, etc.)
• Partners with affiliates to support regulatory agency interactions to expedite approval of pending registration
• Participates/ Awareness on Affiliates Business plans, project plan, regulatory submission strategy, any risks management
• Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations
• Partner with other regulatory functions for smooth project transition and launch
• Submit and review change controls to determine the level of change and consequent submission requirements
• Assist in SOP development and review

Requirements:

• Bachelor's degree in Science/Pharmacy or Math, Engineering, or related medical fields. Master's Degree in a technical area preferred
• Certification such as RAC from the Regulatory Affairs Professionals Society is preferred
• Minimum 3 years of working experience in Regulatory Affairs in Nutrition industry, with some exposure to quality assurance, research and development, scientific affairs preferred
• Strong regulatory knowledge of Regulatory requirements, registration submissions, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc; GxPs (GMPs, GLPs, GCPs); Principles and requirements of promotion, advertising, and labeling
• Good communication skills and ability to communicate effectively verbally and in writing
• Fluent in Mandarin
• Strong attention to detail
• Able to create and manage project plans and timelines.
• Able to think analytically; organize and track complex information
• Proficient computer skills