• Opportunity to join a global pharmaceutical organization.
• Competitive salary and benefits package.

Sobre o nosso cliente

Our client is a leading global pharmaceutical organization with a strong international presence and a diverse portfolio of medicines.

Descrição

• 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.

Perfil ideal

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.

Vantagens

• Opportunity to join a global pharmaceutical organization with a significant international footprint;
• Exposure to high-impact regulatory projects supporting worldwide operations.