CMC Specialist
watton hallNew York (NY)
About the role
CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements throughout the product lifecycle, from development through post-approval.
Main Responsibilities:
Develop and compile high-quality CMC documentation required for regulatory submissions, including INDs, BLAs, NDAs, and variations
Ensure that all documents meet the necessary regulatory standards and guidelines.
Prepare necessary documentation for submission to regulatory authorities regarding these changes.
Work closely with Research & Development (R&D), Quality Assurance (QA), Manufacturing, and other departments to gather technical data and ensure alignment on regulatory strategies.
Serve as a point of contact for interactions with regulatory agencies. Prepare responses to agency inquiries and facilitate meetings as needed.
Provide training to junior staff members on CMC-related regulatory requirements and best practices.
Profile
Minimum of 3 years of experience in Regulatory Affairs focusing on CMC within the pharmaceutical or biopharmaceutical industry.
Bachelors degree in chemistry, biology, biochemistry.
Strong understanding of ICH guidelines, FDA regulations, EMA guidelines, and other relevant international regulations
Benefits:
Remote working opportunity
Competitive salary, bonus and other benefits
Opportunity for professional development and growth
Excellent company culture
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