Regulatory Affairs Associate – Regulatory Information Management

Job Title Regulatory Affairs Associate - Regulatory Information Management RIM - UST Band B1 Role detailed classification RIM Regulatory Information Management Job Summary We are seeking highly skilled and experienced Life Sciences LS Regulatory Affairs RA Associate - RIM to join our LS Practice team The successful candidate will be responsible for LS Regulatory Information Management RIM and or other assigned RA activities The role will involve knowledge of Global Regulatory Affairs guidelines platforms and systems to undertake various assigned roles and responsibilities included but not limited to below described activities Key Responsibilities Life Sciences Regulatory Affairs Associate - RIM plays a crucial role in ensuring compliance within the pharmaceutical medical devices and biotechnology industries by managing the assigned regulatory affairs RIM activities for regulatory submissions health authority queries approvals variations renewals licence maintenance regulatory compliance throughout the product lifecycle This role involves preparing and reviewing regulatory information maintaining compliance with global standards and regulations and utilizing Regulatory systems to track and organize critical data for various assigned activities Specific RIM activities 1 Regulatory Information Management RIM Utilizing the assigned RIM system s to manage and maintain regulatory information track submissions health authority correspondence and approvals across regions and functions Support data migration configuration validation and user acceptance testing UAT 2 Maintain and update regulatory data in RIM systems e g Veeva Vault ArisGlobal EXTEDO etc to ensure accuracy completeness and compliance 3 Support regulatory submissions by coordinating data entry document tracking and metadata management 4 Collaborate with cross-functional teams Regulatory Affairs CMC Clinical Safety to gather and validate submission-related information 5 Monitor regulatory changes and ensure timely updates to product registration and lifecycle data 6 Generate reports and dashboards for regulatory compliance submission tracking and data quality metrics 7 Assist in audits and inspections by ensuring traceability and readiness of regulatory records 8 Participate in system upgrades and validation activities including testing and documentation General responsibilities 9 Compliance and Standards Ensuring adherence to global regulatory guidelines such as ICH ICH-GCP GMP and managing product registration and maintenance across different markets 10 Cross-functional Collaboration Working with various client teams e g RA QA etc to ensure timely and accurate regulatory information and ongoing compliance Monitor regulatory changes and ensure RIM system compliance Support audits and inspections by Notified Bodies and regulatory agencies by maintaining accurate records and submission history 11 Data Management and Reporting Maintaining accurate records of all regulatory activities and leveraging Document Management Publishing and RIM tools to extract insights and support decision-making Qualifications experience Graduate Postgraduate degree in Pharmacy Life Sciences or a related field 4-6 years in LS RA-RIM Knowledge of and Proficiency in Regulatory RIM e-Systems e g Veeva Vault-RIM is mandatory Good to have knowledge of eCTD Lorenz GlobalSubmit etc Proven experience in requirement gathering documentation and stakeholder management Familiarity with eCTD IDMP XEVMPD and GxP compliance Experience with CSV validation support is a plus Basic knowledge of industry standards and regulations related to Quality Management Systems e g ISO 9001 ISO 13485 FDA Global Health authority regulations Experience with other regulatory systems e g ArisGlobal Lorenz MasterControl and knowledge of Veeva Vault Quality is an added advantage Excellent communication collaboration presentation and stakeholder management skills Strong analytical attention to detail and problem-solving abilities Stable track record in LS Regulatory RIM domain in a Mid-large Organisation Proficiency in MS Office Regulatory work processes and good knowledge of Global Regulatory submission requirements especially USFDA MHRA EMA APAC GCC LatAm for Medical Devices and or Medicinal Biotech products Skills Regulatory Affairs RIM systems UAT Data Management Metadata Testing and Documentations About Company UST is a global digital transformation solutions provider For more than 20 years UST has worked side by side with the world s best companies to make a real impact through transformation Powered by technology inspired by people and led by purpose UST partners with their clients from design to operation With deep domain expertise and a future-proof philosophy UST embeds innovation and agility into their clients organizations With over 30 000 employees in 30 countries UST builds for boundless impact touching billions of lives in the process