Regulatory Affairs Specialist – Documentation
Job ID: REQ-10025242
Location: India (Telangana)
Date Posted: 27 November 2025
Employment Type: Full-Time, Regular
Division: Sandoz
Business Unit: Development
Functional Area: Research & Development
Shift: No Shift Work
Position Overview
Sandoz is seeking a highly skilled Regulatory Affairs Specialist – Documentation to support global labelling, regulatory submissions, and compliance documentation. This role plays a critical part in ensuring timely, accurate, and compliant regulatory content for global markets, particularly within the EU region.
This position requires a strong understanding of regulatory guidelines, labelling processes, and safety documentation within the pharmaceutical domain.
Key Responsibilities
Regulatory Documentation & Labelling
Update core texts (SmPCs, PLs, and labelling materials) for EU procedures including MRP, DCP, and CP for variations and renewals.
Coordinate translation activities for centralized procedures and ensure timely delivery to submission teams.
Collaborate with country regulatory teams to support timely submission of labelling updates and changes.
Safety & Compliance Support
Assist Global Labelling Managers in CDS compilation, evaluation of safety label updates, and authoring of associated documents.
Conduct QC reviews for CDS updates, periodic evaluations, and installations to ensure patient safety and regulatory accuracy.
Review safety signals in the tracking system (cdsDB) and evaluate reference product information and regulatory authority communications.
Database & SharePoint Management
Maintain regulatory databases and SharePoint sites as defined by the Global Labelling Team.
Support Compliance Managers in SOP management, PSMF annex updates, deviation handling, and audit/inspection readiness.
Manage training matrices and coordinate assigned labelling or safety projects.
Cross-Functional Coordination & Mentoring
Provide technical and administrative support to Global Labelling Managers and the Head of Global Labelling.
Mentor new team members on regulatory submissions and safety label evaluation, as required.
Experience & Requirements
Essential Qualifications
Minimum 5 years of relevant experience in Regulatory Affairs or Pharmacovigilance, ideally within a global pharmaceutical or generics environment.
Strong experience managing regulatory databases, SharePoint sites, and advanced proficiency in Excel.
Exposure to project management is an added advantage.
Preferred Skills
Structured, detail-oriented, and highly committed.
Strong resilience, flexibility, and ability to work effectively in a global team environment.
Excellent operational excellence mindset with the ability to manage multiple priorities.
Why Join Sandoz?
Sandoz is a global leader in generic and biosimilar medicines, delivering over 900 million patient treatments across 100+ countries in 2024. As the company expands its development capabilities, manufacturing footprint, and global partnerships, this role offers an opportunity to contribute to a meaningful mission—expanding patient access to affordable, high-quality medicines.
Sandoz fosters a collaborative, agile, and growth-focused work culture. Team members benefit from flexible-hybrid work models, diverse global teams, and strong support for career development.
Diversity & Inclusion
Sandoz is committed to building an inclusive workplace where diverse perspectives are valued and where every individual is supported to grow and contribute to global impact.
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