Regulatory Data & Content Specialist – Disclosures
Company: Roche India – Roche Services & Solutions (RSS)
Locations: Chennai / Hyderabad, India
Job Category: Regulatory Affairs / Information Technology
Employment Type: Full-Time
Experience Required: Minimum 4+ Years
Job ID: 202602-102886
About Roche
Roche is a global healthcare leader committed to advancing science to improve patient outcomes worldwide. With over 100,000 employees globally, Roche delivers innovative pharmaceutical and diagnostic solutions that impact millions of lives annually. Roche Services & Solutions (RSS) supports global operations by providing end-to-end business services that enhance operational excellence and regulatory compliance.
Role Overview
Roche is seeking a Regulatory Data & Content Specialist – Disclosures to support regulatory disclosure operations within Pharma Development Regulatory (PDR). This role is critical in ensuring accurate and timely clinical trial disclosures on global public registries such as ClinicalTrials.gov and the EU Clinical Trials Register.
The selected candidate will function as a subject matter expert (SME) in regulatory disclosure processes, clinical trial transparency requirements, and regulatory data governance, contributing to compliant and high-quality regulatory submissions aligned with global standards (GxP, GCP, ICH).
This opportunity is ideal for regulatory professionals with experience in regulatory affairs, regulatory writing, and clinical trial disclosure processes within pharmaceutical or biotechnology organizations.
Key Responsibilities
Act as subject matter expert on product development lifecycle, with focus on regulatory functions and disclosure requirements.
Support posting of clinical trial protocols and results on public trial registries (ClinicalTrials.gov, EU CTR).
Identify applicable studies for disclosure and ensure adherence to regulatory timelines.
Collaborate with cross-functional teams and global affiliates to align on disclosure responsibilities.
Conduct quality control reviews of registry submissions for consistency and compliance.
Coordinate data gathering, documentation approvals, and content validation for regulatory postings.
Monitor workflows and ensure timely completion of disclosure activities.
Track correspondence and manage responses related to registry queries.
Support continuous improvement initiatives within regulatory data and content management processes.
Educational Qualifications
Bachelor’s or Master’s Degree or Pharm.D. in Life Sciences, Pharmacy, Clinical Research, or related discipline.
Certification in Regulatory Affairs or Clinical Research (e.g., PG Diploma) is desirable.
Experience Required
Minimum 4+ years of relevant experience in the pharmaceutical or biotechnology industry.
Proven experience in Regulatory Affairs and Regulatory Writing is highly recommended.
Exposure to clinical trial disclosure processes and product development lifecycle.
Prior experience working in cross-functional, matrix-based environments.
Technical & Functional Skills
Strong understanding of drug development lifecycle and regulatory frameworks (GxP, GCP, ICH guidelines).
Knowledge of global clinical trial transparency and disclosure requirements.
Proficiency in Microsoft Office Suite, Google Workspace, and Adobe Acrobat.
Strong project planning and administrative capabilities.
High attention to detail with ability to manage multiple deadlines.
Core Competencies
Excellent written and verbal communication skills in English.
Strong interpersonal skills with collaborative and partner-service mindset.
Self-motivated, innovative, and solution-oriented approach.
Ability to work independently with minimal supervision.
Adaptability in fast-paced, evolving regulatory environments.
Why Join Roche Services & Solutions?
Opportunity to work within a globally integrated regulatory innovation team.
Exposure to global regulatory operations and disclosure frameworks.
Collaborative work culture focused on continuous improvement and patient-centric innovation.
Career growth within a multinational pharmaceutical leader.
Equal Opportunity Employer
Roche is committed to equal employment opportunity and fosters an inclusive work environment where diversity is valued and respected.
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