At Roche, authenticity is celebrated. The company fosters an inclusive environment where personal expression, open dialogue, and genuine connections thrive. Employees are valued for their unique qualities, enabling personal and professional growth while contributing to preventing, stopping, and curing diseases to ensure global access to healthcare for generations.
Roche Services & Solutions (RSS) transforms how Roche operates as a global team of over 3,500 colleagues. By delivering end-to-end business services, RSS allows Roche partners to prioritize patient-centric activities. With sites in Budapest, Riga, Chennai, Hyderabad, San José, Kuala Lumpur, and beyond, the organization maintains 24/7 customer focus and collaborative solution creation under a OneRoche approach.
Within the Pharma Development Regulatory (PDR) Innovation and Sustainment Chapter, the focus is on building and maintaining business capabilities. The team drives innovation, operational readiness, continuous improvement, and anticipates regulatory shifts to support PDR’s ambitious goals and Pharma vision. Emphasis is placed on compliant, efficient processes, systems, tools, data integrity, and submission quality.
As a Regulatory Information Specialist, you will serve as a key contributor by managing regulatory correspondence with global Health Authorities. Your work ensures the Regulatory Information Management (RIM) database acts as the single source of truth, upholding data integrity and compliance to support audits and drug development milestones. A major aspect involves converting unstructured FDA regulatory documents into structured, actionable insights.
Roles & Responsibilities
- Process and upload regulatory correspondence (letters, emails, meeting minutes) into the RIM system with 100% accuracy, aligning with eCTD structure.
- Review incoming documents for accurate metadata categorization and identify agency commitments or deadlines to alert stakeholders.
- Conduct in-depth data extraction from FDA Summary Basis of Approval (SBA) reviews, including trial designs, sample sizes, and dosing regimens.
- Capture primary/secondary endpoints and statistical results (e.g., P-values, Hazard Ratios, Confidence Intervals).
- Identify key regulatory milestones like breakthrough designations, orphan drug status, and RMAT.
- Document Advisory Committee meeting details, voting outcomes, and discussions from FDA briefing materials.
- Maintain database consistency through cross-referencing multiple FDA sources (e.g., Drugs@FDA) using standardized nomenclature.
- Support internal audits and health authority inspections by enabling fast document retrieval.
Required Qualifications
- Bachelor’s or Master’s degree (or Pharm D) in Life Sciences, Pharmacy, Clinical Research, or equivalent.
- 2–4 years of experience in Regulatory Operations, Document Management, or related clinical research/regulatory affairs roles.
- Foundational knowledge of the drug development lifecycle and health authorities (FDA, EMA, etc.).
- Strong FDA literacy, including familiarity with CDER and CBER approval package structures.
- Solid clinical knowledge to interpret trial results (e.g., double-blind studies, non-inferiority, ITT analysis).
- Proficiency in RIM tools (e.g., Veeva Vault), Microsoft Excel, Google Sheets; quick adaptability to new technologies.
- Exceptional attention to detail and commitment to right-first-time data accuracy.
- Excellent written English for summarizing complex regulatory information; ability to handle high-volume work under tight deadlines.
- Certification in Regulatory Affairs (e.g., PG diploma) is an advantage.
Salary, Benefits & How to Apply The role is based primarily in Hyderabad (with availability in Chennai), India. Roche offers competitive compensation in the Indian pharma sector for this level (typically ₹8-15 lakhs per annum base, depending on experience, plus benefits—exact details provided during hiring). Benefits include a supportive, inclusive culture, opportunities for growth in a global organization, health and wellness programs, and contributions to meaningful healthcare advancements.
Roche is an Equal Opportunity Employer dedicated to diversity and inclusion.
To apply, visit the Roche careers portal and search for Job ID 202602-102922 (Regulatory Information Specialist). Submit your resume and cover letter highlighting relevant regulatory experience. Early applications are encouraged as this position supports critical drug development initiatives.
