Global Regulatory Affairs Specialist

5 hours ago

Mumbai, India G&L Scientific Full time

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.

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