Job Description
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-approvalMain 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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