Regulatory Data & Content Specialist - Disclosures

Roles & Responsibilities
• Act as a subject matter expert across the product development lifecycle with focus on regulatory functions
• Support disclosure of clinical trial protocols and results on ClinicalTrials.gov and EU Clinical Trials Register
• Identify clinical studies requiring disclosure and track submission timelines
• Coordinate with global project teams and affiliates to meet disclosure obligations
• Perform quality control checks on registry submissions to ensure accuracy and compliance
• Collect, manage, and maintain regulatory data, approvals, and supporting documentation
• Monitor workflows to ensure timely postings and regulatory compliance
• Track correspondence and resolve disclosure-related queries with internal stakeholders
• Ensure adherence to GxP, GCP, ICH guidelines, and global disclosure regulations

Qualifications
• Bachelor’s / Master’s / PharmD in Life Sciences, Pharmacy, Clinical Research, or equivalent

Experience
• Minimum 4 years of experience in Regulatory Affairs, Regulatory Writing, or Clinical Trial Disclosures

Skills
• Strong understanding of GxP, GCP, ICH guidelines, and clinical trial disclosure requirements
• Experience with ClinicalTrailsgov and EU disclosure registries
• Proficiency in MS Office, Google Workspace, and Adobe Acrobat
• Strong documentation, data management, and quality review skills
• Excellent communication, coordination, and project management abilities
• Ability to work independently in a fast-paced, global environment
• Certification or PG Diploma in Regulatory Affairs / Clinical Research (preferred)

About the Organization
Roche is a global pioneer in pharmaceuticals and diagnostics, committed to advancing science to improve people’s lives. Through Roche Services & Solutions (RSS), the organization delivers high-impact, patient-focused regulatory and operational support worldwide, offering a collaborative environment, global exposure, and long-term career growth opportunities.