Roche Hiring Regulatory Information Specialist in Chennai & Hyderabad – Global Regulatory Operations Role

Roche is hiring for the role of Regulatory Information Specialist under Roche Services & Solutions (RSS) in Chennai and Hyderabad. This is a full-time position supporting global regulatory operations within Pharma Development Regulatory (PDR). The opening is suitable for professionals with 2–4 years of experience in regulatory operations, document management, or clinical research–related roles. This role focuses on regulatory correspondence management, Regulatory Information Management (RIM) systems, FDA data extraction, and audit readiness. The position is available across two locations in India and offers exposure to global health authority interactions and drug development programs.

This opportunity is ideal for life sciences, pharmacy, and clinical research professionals aiming to build long-term careers in regulatory operations, regulatory intelligence, and global compliance within a multinational healthcare organization.

Company Overview

Roche is a global leader in pharmaceuticals and diagnostics, driven by a purpose to advance science and ensure access to healthcare for patients worldwide. With operations across research, development, manufacturing, and commercial functions, Roche has built a strong reputation for innovation, ethics, and patient-centricity.

Roche Services & Solutions (RSS) is a global organization that enables Roche to operate efficiently in a dynamic and competitive healthcare environment. With a workforce of over 3,500 professionals across locations including India, Europe, Southeast Asia, and the Americas, RSS delivers end-to-end business services that allow core teams to focus on patient impact.

Within RSS, the Pharma Development Regulatory (PDR) function plays a critical role in maintaining compliant, efficient regulatory processes and systems. The PDR Innovation and Sustainment Chapter focuses on regulatory readiness, continuous improvement, and future-focused capabilities that support global drug development and submission quality.

Job Role & Responsibilities

As a Regulatory Information Specialist, you will be responsible for managing regulatory correspondence and structured regulatory data to ensure accuracy, compliance, and audit readiness across global programs. The role combines regulatory operations, data intelligence, and quality-focused documentation management.

Regulatory Correspondence & RIM Management

Process and upload regulatory correspondence including letters, emails, and meeting minutes into the RIM system with complete accuracy
Ensure documents are archived according to eCTD structure and internal regulatory standards
Maintain the RIM database as a single source of truth with high data integrity

Regulatory Data Extraction & Analysis

Perform detailed data extraction from FDA Summary Basis of Approval reviews
Capture clinical trial designs, sample sizes, dosing regimens, endpoints, and statistical outcomes
Accurately document p-values, hazard ratios, confidence intervals, and key efficacy and safety data

Regulatory Intelligence & Milestone Tracking

Identify and extract regulatory milestones such as breakthrough therapy designation, orphan drug status, and RMAT
Document advisory committee meeting dates, voting outcomes, and key discussion points
Cross-reference multiple regulatory data sources to ensure consistency and standardized nomenclature

Compliance, Audits & Inspections

Flag regulatory commitments and deadlines for relevant internal stakeholders
Support internal audits and health authority inspections by enabling rapid document retrieval
Collaborate with quality and regulatory teams to ensure inspection readiness

Process Improvement & Collaboration

Contribute to continuous improvement initiatives across regulatory processes, tools, and systems
Collaborate with enterprise teams across Pharma Development, affiliates, and quality organizations
Support transformation initiatives that improve regulatory submission quality and operational efficiency

Eligibility / Qualifications

This role is designed for candidates with a strong foundation in regulatory operations and drug development documentation.

Educational Qualifications

Eligible qualifications include:

B.Pharm, M.Pharm, PharmD, B.Sc Life Sciences, M.Sc Life Sciences, Clinical Research, Pharmaceutical Sciences, Biological Sciences

A postgraduate diploma or certification in Regulatory Affairs is considered an added advantage.

Experience Requirements

2 to 4 years of experience in regulatory operations, document management, or clinical research support roles
Prior exposure to regulatory submissions, regulatory correspondence, or health authority documentation is preferred

Technical & Regulatory Competencies

Foundational understanding of the drug development lifecycle
Familiarity with global health authorities including FDA and EMA
Strong FDA literacy with understanding of CDER and CBER approval packages
Ability to interpret clinical trial terminology and outcomes
Proficiency in RIM systems such as Veeva Vault and strong skills in Microsoft Excel and Google Sheets
High attention to detail with a right-first-time approach to data quality
Strong written communication skills for summarizing regulatory decisions

Location & Salary

Job Locations: Chennai, Tamil Nadu | Hyderabad, Telangana

Roche Hiring – Regulatory Information Specialist

Application Process

Interested candidates must apply through Roche’s official career portal using the link below:

Apply Online:
https://careers.roche.com/global/en/job/ROCHGLOBAL202602102922EXTERNALENGLOBAL/Regulatory-Information-Specialist

Candidates are encouraged to apply promptly, as applications are reviewed on a rolling basis.

Frequently Asked Questions (FAQs)

Who can apply for the Regulatory Information Specialist role at Roche?
Candidates with life sciences or pharmacy backgrounds and 2–4 years of regulatory operations or document management experience can apply.

Is this a regulatory affairs role?
This is a regulatory operations and regulatory information management role supporting global submissions and compliance.

Which health authorities does this role support?
The role primarily supports FDA-related documentation and global regulatory intelligence, with exposure to EMA and other authorities.

Is this role suitable for clinical research professionals?
Yes. Candidates with clinical research and regulatory documentation experience are well suited for this position.

Is this a permanent position?
Yes. This is a full-time permanent role at Roche Services & Solutions.