Global Regulatory Affairs Specialist

4 hours ago

Navi Mumbai, Maharashtra, India G&L Scientific Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Contract: Permanent Full-Time

Closing Date: 05/12/25

We are seeking 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.

The Role

Key Responsibilities:

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

Labeling Activities

  • Review and update product labeling in accordance with regulatory and internal requirements
  • Ensure alignment between approved labeling 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
Requirements

Required Skills & Experience:

  • 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.

How to Apply

If you would be interested in joining the team at G&L Scientific, please send your CV to [email protected] today.

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.

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