Regulatory Information Specialist
Company: Roche India – Roche Services & Solutions (RSS)
Locations: Chennai / Hyderabad, India
Job Category: Regulatory Affairs / Regulatory Operations / Information Technology
Employment Type: Full-Time
Experience Required: 2–4 Years
Job ID: 202602-102922
About Roche
Roche is a global healthcare leader committed to advancing science and improving patient outcomes worldwide. With a strong global footprint and a workforce of over 100,000 professionals, Roche delivers innovative pharmaceutical and diagnostic solutions that transform lives. Roche Services & Solutions (RSS) supports global operations through integrated business services, enabling regulatory excellence and operational efficiency.
Role Overview
Roche is hiring a Regulatory Information Specialist to support regulatory operations within the Pharma Development Regulatory (PDR) Innovation and Sustainment Chapter. This role is critical in managing regulatory correspondence, maintaining data integrity within Regulatory Information Management (RIM) systems, and ensuring compliance with global health authority requirements.
The selected candidate will serve as a key contributor in transforming unstructured regulatory documents into structured, actionable intelligence that supports submission quality, audit readiness, and global drug development milestones.
This opportunity is ideal for regulatory professionals with experience in regulatory operations, document management, and regulatory data governance within pharmaceutical or biotechnology organizations.
Key Responsibilities
Process, review, and upload regulatory correspondence (letters, emails, meeting minutes) into the RIM system with 100% accuracy.
Ensure documents are filed according to eCTD structure and global regulatory standards.
Categorize metadata accurately and identify health authority commitments, deadlines, and regulatory obligations.
Extract critical regulatory data from FDA Summary Basis of Approval (SBA) reviews, including trial design, dosing regimens, and sample sizes.
Record clinical trial endpoints, statistical outcomes (P-values, Hazard Ratios, Confidence Intervals), and regulatory milestones.
Capture information on breakthrough designations, orphan drug status, RMAT designations, and advisory committee outcomes.
Cross-reference data across FDA databases such as Drugs@FDA to maintain standardized nomenclature and consistency.
Support audit readiness and health authority inspections by enabling rapid documentation retrieval.
Maintain RIM database integrity as the single source of truth for regulatory information.
Educational Qualifications
Bachelor’s, Master’s Degree, or Pharm.D. in Life Sciences, Pharmacy, Clinical Research, or a related field.
Certification in Regulatory Affairs (e.g., PG Diploma in Regulatory Affairs or Clinical Research) is an added advantage.
Experience Required
2–4 years of experience in Regulatory Operations, Regulatory Affairs, Document Management, or related clinical research roles.
Hands-on experience working with Regulatory Information Management (RIM) systems such as Veeva Vault.
Exposure to FDA regulatory documentation and approval packages (CDER and CBER preferred).
Familiarity with global regulatory frameworks and health authorities including FDA and EMA.
Technical & Functional Skills
Strong understanding of drug development lifecycle and regulatory submission processes.
Proficiency in RIM software (e.g., Veeva Vault), Microsoft Excel, and Google Sheets.
Ability to interpret clinical trial methodologies (double-blind, non-inferiority, ITT analysis).
Strong FDA literacy and familiarity with regulatory approval documentation.
Exceptional attention to detail and data accuracy mindset.
Ability to manage high-volume documentation under strict timelines.
Core Competencies
Strong written English skills for summarizing complex regulatory decisions.
High level of analytical thinking and structured data extraction capability.
Strong collaboration skills in cross-functional and matrix-based environments.
Ability to work independently with minimal supervision.
Detail-oriented with a right-first-time approach to regulatory data management.
Why Join Roche Services & Solutions?
Work within a globally integrated regulatory innovation team.
Exposure to high-impact global regulatory operations and FDA documentation analysis.
Opportunity to contribute to audit readiness, submission quality, and regulatory intelligence.
Career growth within a multinational pharmaceutical organization.
Equal Opportunity Employer
Roche is committed to equal employment opportunity and fosters an inclusive workplace where diversity, innovation, and collaboration drive success.
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