Chief CMC Compliance Officer

4 days ago

Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000

Job Summary:

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  • We are seeking a seasoned Regulatory Affairs professional to lead our CMC regulatory activities for USFDA submissions.
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About the Role:

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This Senior Regulatory Affairs Specialist will oversee and manage various aspects of CMC regulatory activities, including preparing and reviewing technical documents, coordinating product compliance, and staying updated on evolving USFDA regulations.

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Key Responsibilities:

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  • Develop and implement effective strategies for CMC regulatory activities, ensuring compliance with USFDA guidelines and regulatory frameworks.">
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Requirements:

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  • Minimum 7 years of experience in Regulatory Affairs – CMC with USFDA filings.
  • Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Proven ability to prepare and review technical documents, as well as interact with cross-functional teams.
  • Excellent communication and project management skills.
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What We Offer:

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Our company provides a dynamic work environment, opportunities for growth and development, and a competitive compensation package.

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How to Apply:

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To be considered for this exciting opportunity, please submit your resume and cover letter outlining your qualifications and experience.

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