At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Regulatory Information Specialist

Roche India – Roche Services & Solutions 

Chennai/ Hyderabad

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 

That’s what makes us Roche.

Mission

Roche Services & Solutions (RSS) aims at \"transforming the way Roche operates.'' As a global organization of over 3,500 colleagues, we enable Roche to operate in a competitive and ever-changing business environment. We provide our partners with end-to-end business services and solutions, enabling them to focus on patient-centric activities. Embracing an OneRoche mindset, we leverage our global network located in Budapest (Hungary), Riga (Latvia), Chennai & Hyderabad (India), San José (Costa Rica), Kuala Lumpur (Malaysia), and our other sites to remain customer-centric 24/7 and co-create solutions together.

The Pharma Development Regulatory (PDR) Innovation and Sustainment Chapter is responsible for developing and sustaining business capabilities within PDR. We focus on fostering innovation, ensuring operational readiness, and implementing continuous improvements. Our team anticipates regulatory landscape changes and evaluates future business needs to achieve PDR's moonshots and Pharma vision. We maintain compliant, efficient regulatory processes, systems, and tools to meet patient and business needs, and understand the impact of data and information on submission quality.

As a member of this chapter, you will leverage talent across PDR to drive innovation, lead continuous improvement, and oversee regulations and internal standards. Your responsibilities include assessing processes, tools, and technology to achieve our business goals, collaborating enterprise-wide to ensure compliance, and partnering with quality organizations across PD, affiliates, Pharma, and Roche.

As a Regulatory Information Specialist, you will manage the intake, analysis, and archiving of official correspondence between the company and global Health Authorities. You will ensure that our Regulatory Information Management (RIM) database remains the \"single source of truth,\" maintaining high standards of data integrity and compliance to support audit readiness and drug development milestones. You will play a pivotal role in transforming unstructured FDA regulatory documents into structured, actionable intelligence.

The Opportunity

You process and upload regulatory correspondence (letters, emails, meeting minutes) into the RIM system with 100% accuracy, ensuring documents are filed according to eCTD structure.

You review incoming documents to correctly categorize metadata and identify specific \"agency commitments\" or deadlines to flag for relevant stakeholders.

You perform deep-dive data extraction from FDA Summary Basis of Approval (SBA) reviews, capturing pivotal trial designs, sample sizes, and dosing regimens.

You accurately record primary/secondary endpoints and statistical outcomes (e.g. P-values, Hazard Ratios, Confidence Intervals).

You identify and extract key regulatory milestones, such as breakthrough designations, orphan drug status, and RMAT.

You document Advisory Committee meeting dates, voting outcomes, and key discussion points from FDA briefing materials.

You maintain database integrity by cross-referencing data across multiple FDA sources (e.g., Drugs@FDA) to ensure consistency and standardized nomenclature.

You assist in internal audits and health authority inspections by providing rapid retrieval of requested documentation.

Who You Are

You hold a Bachelor’s or Master’s Degree or Pharm D in Life Sciences, Pharmacy, Clinical Research, or an equivalent field.

You have 2–4 years of experience in Regulatory Operations, Document Management, or a related clinical research/regulatory affairs role.

You have a foundational understanding of the drug development lifecycle and the role of health authorities such as the FDA, EMA etc..

You possess strong FDA Literacy, with familiarity in the structure of FDA approval packages for both CDER and CBER.

You have a solid clinical understanding, including the ability to interpret trial results and terms like double-blind, non-inferiority, and ITT analysis.

You are proficient with RIM software (e.g., Veeva Vault), Microsoft Excel, and Google Sheets; you are a quick learner of new technologies.

You demonstrate meticulous attention to detail (e.g., distinguishing between a 0.05 and 0.005) and a \"right-first-time\" approach to data entry.

You have strong written English skills for summarizing complex regulatory decisions and are comfortable managing high volumes of documentation under tight timelines.

A certification in a Regulatory Affairs course (e.g., PG diploma) is considered an asset.

 

 

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Hyderabad. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.