Global Regulatory Affairs Specialist – Product Lifecycle

4 weeks 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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