Regulatory Affairs Specialist

16 hours ago

Hyderabad, Telangana, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

Job Title:

Regulatory Affairs Specialist - CMC Strategy

Job Summary:

  • We are seeking a skilled professional to develop and execute CMC regulatory strategies for assigned products, ensuring global compliance.

Key Responsibilities:

  1. Develop and execute comprehensive CMC regulatory strategies for assigned products across the product lifecycle.
  2. Lead the development, review, and approval of CMC submission components and documentation.
  3. Evaluate and prepare change control documents for life-cycle changes to commercial products.
  4. Collaborate with internal and external partners to support compliant execution of change management.
  5. Manage execution of CMC documentation, including post-approval variations and registration renewals.
  6. Demonstrate a robust understanding of regulatory affairs and apply this knowledge to ensure approval and product supply continuity.
  7. Assess and communicate potential regulatory risks and propose mitigation strategies.
  8. Deliver all regulatory milestones for assigned products across the product lifecycle.

Requirements:

  • Bachelor's/Master's/Ph.D. degree in science or a life sciences discipline.
  • 10+ years of experience preferred, with strong experience in CMC registration and pre/post-approval submission activities.
  • Superior oral and written communication skills in multicultural settings.
  • Strong listening skills and sound understanding of related fields.

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