Global Regulatory Affairs Specialist – Product Lifecycle

We are seeking three Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle management activities. This opportunity can be located from our office locations in Mumbai and Hyderabad

Duties will include:

CMC Documentation Support

• Compile, review, and maintain Chemistry, Manufacturing, and Controls (CMC) documentation
• Coordinate with Quality, Manufacturing, and regulatory teams to ensure accuracy and completeness

Labelling Activities

• Review and update product labelling in accordance with regulatory and internal requirements
• Ensure alignment between approved labelling and market implementation

Regulatory Operations & Lifecycle Management

• Support preparation, review, and submission of regulatory filings
• Ensure compliance with CHC regulatory standards, policies, and timelines
• Contribute to lifecycle activities including variations, renewals, and maintenance submissions

Person Specification

• Experienced in Regulatory Affairs, ideally with exposure to CMC, labelling, or lifecycle management
• Detail-oriented, organized, and comfortable coordinating across multiple functions
• Able to manage priorities in a fast-moving, global environment
• Strong communicator with a compliance-focused mindset

Why join G&L?

This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants.

If you're passionate about regulatory excellence and digital transformation in life sciences, we’d love to hear from you.