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Global Regulatory Affairs Specialist – Product Lifecycle

Global Regulatory Affairs Specialist – Product Lifecycle

G&L ScientificRepublic Of India, IN
4 days ago
Job description

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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    Regulatory Specialist • Republic Of India, IN

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