This is a fully remote position, open to applicants in Slovakia, +1 more country.

📋 Description

• Act as the main point of contact for internal users of Regulatory Information Management systems, offering support and resolving issues.

• Develop and uphold submission frameworks, regulatory records, and business data attributes within the RIM environment.

• Design and oversee system templates, including those for submission assembly and related configurations.

• Execute data entry, data cleansing, and master data governance tasks to ensure the accuracy and integrity of data.

• Assist with the implementation and maintenance activities linked to the RIM modernization initiative.

• Engage in project meetings, providing updates on status, identifying risks, and aiding in mitigation efforts for assigned tasks.

• Ensure compliance with RIM standards, procedures, and work instructions to meet regulatory compliance requirements.

• Recognize opportunities to enhance system processes, data quality, and user experience through ongoing improvement initiatives.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Public Health, Business, or a related field, along with 2+ years of experience supporting Regulatory Information Management systems, Regulatory Affairs processes, or master data management; or a Master's degree with 1+ year of pertinent experience.

• Familiarity with the regulatory affairs lifecycle and regulatory submission protocols.

• Experience providing support to end users, managing requests, or addressing system-related challenges.

• Proficient in using Microsoft Office applications, particularly Excel.

• Proven ability to handle multiple assignments while ensuring accuracy and attention to detail.

• Experience in a medical device, pharmaceutical, or life sciences setting, along with familiarity in data governance, data quality management, or system implementation projects, is preferred.