As a Regulatory Information Management (Rim) Specialist, you will manage regulatory information to help maintain accurate and accessible records within the Life Science industry. You will work with regulatory data and documentation, supporting clear information handling across relevant business activities.
Description
- Create, update, and maintain regulatory records, activities, and data objects within the RIM system;
- Partner closely with Regulatory Affairs teams to support regulatory data management activities;
- Ensure information submitted to and received from Health Authorities is accurately captured and maintained within established timelines;
- Support data validation activities through reports, queries, and quality reviews;
- Participate in data cleansing initiatives to improve data integrity and accessibility across key systems;
- Investigate and resolve data quality issues, implementing corrections where required;
- Coordinate master data requests and support dictionary updates within the RIM environment;
- Respond to regulatory data queries from internal stakeholders and escalate complex issues when necessary;
- Identify opportunities to enhance processes, systems, and ways of working;
- Contribute to the development and maintenance of SOPs, user guides, and regulatory data standards;
- Collaborate with cross-functional and international teams to support global regulatory initiatives.
Profile
A successful 'Regulatory Information Management (Rim) Specialist' should have:
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related discipline;
- Minimum of 3 years' experience within the pharmaceutical industry, ideally in Regulatory Affairs or Regulatory Operations;
- Experience working with Regulatory Information Management (RIM) systems; exposure to Veeva RIM will be considered a strong advantage;
- Knowledge of eCTD structures and regulatory submission processes is highly valued;
- Strong organizational skills with the ability to manage multiple priorities simultaneously;
- High level of accuracy and attention to detail;
- Comfortable working with complex systems and digital tools;
- Advanced knowledge of Microsoft Office applications, particularly Excel;
- Strong communication and stakeholder management skills;
- Ability to thrive in a global, cross-functional environment;
- Fluency in English.
Job Offer
- Opportunity to join a global pharmaceutical organization with a significant international footprint;
- Exposure to high-impact regulatory projects supporting worldwide operations.
Apply to discuss the Regulatory Information Management (Rim) Specialist role in more detail.