CMC Regulatory Strategist

2 days ago


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

About Our CMC Regulatory Role:

Seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to lead global CMC submission activities.

  • Develop and implement strategic plans for global CMC regulatory submissions.
  • Lead and manage global CMC submission projects.
  • Author high-quality CMC documentation for health authority submissions.
  • Ensure technical congruency and regulatory compliance across regions.
  • Collaborate with cross-functional teams to address quality and compliance issues.
  • Prepare risk management assessments and contingency plans.

Requirements and Qualifications:

  • Pharmaceutical industry experience in CMC.
  • Strong knowledge of regulatory guidelines, particularly those related to CMC.
  • Proven track record of leading global CMC submission activities.
  • Excellent communication and project management skills.
  • Bachelor's degree in a relevant field.

Job Responsibilities:

  • Develop strategic plans for global CMC regulatory submissions.
  • Manage global CMC submission projects.
  • Author CMC documentation for health authority submissions.
  • Ensure technical congruency and regulatory compliance.
  • Collaborate with cross-functional teams.
  • Prepare risk management assessments.

Why This Role is Important:

This role plays a critical part in ensuring the success of our CMC submission activities. If you have expertise in this area and are looking for a challenging opportunity, please apply.



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