Regulatory Information Specialist

Roles & Responsibilities:
• Process and upload regulatory correspondence (letters, emails, meeting minutes) into RIM systems in alignment with eCTD structure
• Ensure accurate metadata classification and identify regulatory commitments and health authority deadlines
• Extract structured data from FDA Summary Basis of Approval (SBA) documents, including trial design, sample size, and dosing details
• Capture clinical endpoints, statistical outcomes (P-values, Hazard Ratios, Confidence Intervals), and regulatory conclusions
• Identify and document key regulatory milestones such as Breakthrough Therapy, Orphan Drug Designation, and RMAT
• Review and summarize Advisory Committee meeting content, voting results, and key discussions
• Maintain database consistency through cross-referencing FDA sources (e.g., Drugs@FDA) using standardized terminology
• Support internal audits and health authority inspections through efficient document retrieval and data accuracy
• Ensure RIM database serves as a single source of truth with 100% data integrity

Qualification:
• Bachelor’s / Master’s degree or Pharm D in Life Sciences, Pharmacy, Clinical Research, or related discipline

Experience:
• 2–4 years of experience in Regulatory Operations, Regulatory Information Management, Document Management, or Clinical Research

Skills:
• Strong understanding of drug development lifecycle and global health authorities (FDA, EMA, etc.)
• Good knowledge of FDA CDER/CBER approval package structures
• Ability to interpret clinical trial data (double-blind studies, ITT analysis, non-inferiority trials)
• Hands-on experience with RIM tools such as Veeva Vault (preferred)
• Proficiency in MS Excel, Google Sheets, and document management systems
• Excellent written English with strong summarization skills
• High attention to detail and ability to manage high-volume work under strict timelines
Preferred:
• Certification or PG Diploma in Regulatory Affairs
• Experience supporting audits and regulatory inspections

About the Organization:
Roche is a global healthcare leader committed to innovation, inclusion, and patient-centric solutions. Roche Services & Solutions enables Roche teams worldwide by delivering high-quality end-to-end business services with a OneRoche mindset.