Sandoz Hiring for Regulatory Affairs Documentation Role

Sandoz, a global leader in generic and biosimilar medicines, is hiring a Regulatory Affairs Senior Specialist – Documentation for its Development division in Telangana, India. This role is ideal for regulatory professionals with strong expertise in CMC documentation, Module 3 submissions, and global regulatory compliance.

As part of Sandoz’s Regulatory Affairs team, you will contribute directly to high-quality, affordable medicines that impact millions of patients worldwide. This position offers exposure to global health authority submissions, lifecycle management, and cross-functional regulatory strategy in a collaborative R&D environment.

Key Responsibilities

• Plan, author, compile, and submit CMC regulatory documents with accuracy and timeliness
• Prepare and manage Module 3 dossiers, Drug Master Files (DMFs), and submission packages
• Ensure regulatory compliance in line with ICH Q11, ICH M7, and global guidelines
• Coordinate submissions to Health Authorities during development, registration, and lifecycle phases
• Prepare and respond to health authority CMC queries
• Review manufacturing, control, and starting material information for regulatory adequacy
• Assess regulatory impact of CMC changes and determine submission strategies
• Support preparation of internal SOPs and regulatory guidance documents
• Collaborate with cross-functional stakeholders and provide regulatory guidance
• Maintain up-to-date regulatory knowledge and support internal knowledge transfer

Required Qualifications & Skills

• Strong scientific and technical writing skills
• Good working knowledge of Module 3 (CMC) documentation
• Basic understanding of global regulatory guidelines
• Proficiency in MS Word and Excel
• Excellent documentation skills with strict adherence to SOPs
• Ability to work independently under minimal supervision

Why Join Sandoz?

• Work with a global leader in generic and biosimilar medicines
• Contribute to medicines impacting ~500 million patients annually
• Exposure to global regulatory strategies and submissions
• Open, collaborative, and inclusive work culture
• Strong focus on career growth, learning, and flexibility

Job Details

• Company: Sandoz
• Job Title: Regulatory Affairs Senior Specialist – Documentation
• Job ID: REQ-10024332
• Location: Telangana, India
• Functional Area: Research & Development
• Employment Type: Full-time | Regular
• Shift: Day shift (No shift work)

How to Apply

Application Link