Global Regulatory Expert

4 days ago

Hyderabad, Telangana, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Regulatory Compliance Specialist

A key role that demands expertise in regulatory affairs and the ability to manage global CMC submission activities with strategic oversight.

Key Responsibilities:
  • Develop, implement, and maintain global CMC regulatory strategies that align with business objectives while ensuring compliance with regulatory requirements.
  • Oversee and coordinate global CMC submission activities, encompassing planning, content creation, review, coordination, and submission.
  • Author and/or review high-quality CMC documentation for regulatory submissions, ensuring accuracy, clarity, and adherence to guidelines.
  • Ensure technical consistency and regulatory compliance across all regions through proactive monitoring and corrective action.
  • Collaborate with cross-functional teams to identify and address quality and compliance issues, promoting a culture of excellence.
  • Prepare and communicate CMC risk management assessments and contingency plans, providing strategic insights to drive informed decision-making.
Requirements:
  • Proven experience in the pharmaceutical industry, focusing on chemistry, manufacturing, and control.
  • Extensive knowledge of regulatory frameworks, particularly those related to CMC, with a strong understanding of international regulations and guidelines.
  • Demonstrated track record of successfully leading global CMC submission activities with a focus on quality and compliance.
  • Excellent communication, project management, and leadership skills, with the ability to work effectively in a fast-paced environment.
  • Bachelor's degree in a relevant field, such as pharmaceutical science or chemistry, with a strong academic background.

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