Specialist-Regulatory Affairs CMC

12 hours ago

Bengaluru, Karnataka, India Clinchoice Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Primary Responsibilities:

  • Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.
  • Responsible for writing CMC modules 2 & 3.
  • Exposure to EU & CIS region in Regulatory filings
  • Manage and coordinate product life cycle management.
  • Ensure regulatory compliance with local regulatory requirements.
  • Foster and maintain professional relationships with the health authorities.
  • Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary.
  • Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
  • Promote regulatory intelligence in both local and regional initiatives.
  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
  • Responsible for reviewing CMC modules.
  • Execution of regulatory strategies (local and regional) in line with business plan.
  • Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
  • Ensure to adherence to timelines and quality set parameters.
  • Review of Formulation, generation of ingredient list and Claims as per set standards.

Qualification

  • Minimum B.S. Chemistry, Pharmacy or related scientific field
  • Experience in CMC regulatory affairs for pharmaceutical products.
  • Experience in Module 3, Module 2.3 and relevant Module 1 e-CTD documentation

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