Regional Regulatory Affairs Officer, Vifor Singapore

Main Accountabilities

• Represent Regulatory Affairs on various cross-functional teams
• Contribute to the development of project plans and other deliverables
• Document Control
• Create and revise procedures as needed
• Review and approve change orders and evaluate for submission requirements
• Internal Audits coordination and support

• Aligned and compliant regulatory preparations and on time submission on assigned products
• Effective monitoring and follow up on products submission progress
• Proper and in time documentation and filing of regulatory records and data with efficient access to relevant stakeholders
• Close collaboration with distributors to ensure up to date knowledge sharing and distributors' capabilities in regulation activities

• Perform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements
• Compile all dossiers required in submissions, license renewal and GMP clearance renewal
• Monitor and maintain database of registration and status - ensure proper filing and records of regulatory documentation are kept
• Keep abreast of regulatory procedures and changes
• Recommend strategies for earliest possible approvals of applications
• Effective communication between global, HQ RA to ensure implementation of all strategic plans
• Lead and drive RA activities in accordance with local requirements to ensure the Company's products are registered on time or life cycle management in the markets are in scope of responsibility, and post marketing surveillance risks are minimized

• Responsible for Regulatory monitoring and analysis of new or updated local legislation and for ensuring in-time registration in the relevant countries
• Create a regulatory plan and a labelling plan (when needed) to ensure consistency
• Improve efficiency of RA team to create a cogent process of documents/data management/storage and/or document flow which is easy and efficient for access to relevant stakeholders
• Provide training and knowledge sharing session to the Company's associates and distributors to ensure all parties understand and comply to all relevant local regulations
• Responsible for monitoring distributors' competencies in regulation activities, and to provide effective solution to ensure quality RA work could be carried out.

• Strong knowledge of local regulatory requirements including submissions requirements, labelling and regulations, auditing principles and adverse event reports
• Minimum 2 years of related experience
• Bachelor's degree in Pharmacy or Science related qualification
• Strong writing, editing and analytical skills
• Some Pharmacovigilance exposure will be a bonus

• Team player with ability to work within a cross-functional team environment
• Ability to multi-task and prioritize
• Strong organization skills with high resilience level
• Able to work with ambiguity
• Candidates with more experience and ability to handle more complex operations may be considered at a manager level.