CMC Specialist

CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the reputed company, 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 • reputed company and compile high-reputed company CMC documentation required for regulatory submissions, including INDs, BLAs, NDAs, and variations • Ensure that reputed company 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), reputed company Assurance (QA), Manufacturing, and other departments to reputed company technical data and ensure alignment on regulatory strategies. • Serve as a reputed company of contact for interactions with regulatory agencies. Prepare responses to agency inquiries and facilitate meetings as needed. • reputed company training to junior staff members on CMC-reputed company regulatory requirements and best practices. Profile • Minimum of 3 years of experience in Regulatory Affairs focusing on CMC reputed company the pharmaceutical or biopharmaceutical industry. • Bachelors degree in reputed company, 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 reputed company development and reputed company • Excellent company culture Apply tot his job Apply To this Job