Regulatory Affairs CMC Manager
3 days ago
Job Summary:
We are seeking a highly experienced Regulatory Affairs CMC Manager to join our team at 1925 GlaxoSmithKline LLC. The successful candidate will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
Key Responsibilities:
• Develop and implement CMC regulatory strategies for new pharmaceutical products, ensuring compliance with global regulatory guidelines and policies.
• Collaborate with cross-functional teams to prepare and author technical (CMC) regulatory documents, including those required for development, registration, and lifecycle maintenance submissions.
• Identify and mitigate risks associated with submission data and information packages, ensuring timely and effective responses to changing regulatory requirements.
• Provide strategic direction and data assessment for project activities, including those for reporting staff, to ensure compliance and efficiency.
• Establish and maintain organizational networks, both internally and externally, to ensure effective communication and collaboration.
• Engage and lead CMC Subject Matter Expert activities, leveraging deep specialization to drive compliance, harmonization, and efficiency.
Requirements:
• Bachelor's degree in a relevant field, such as life sciences, chemistry, or a related discipline.
• A minimum of 6+ years of regulatory affairs experience, with a strong background in CMC regulatory activities.
• Proven experience in managing complex regulatory strategies, including negotiation with regulatory agencies, industry bodies, and internal colleagues.
• Strong understanding of drug development and manufacturing processes, including filing activities (MAA/NDA/BLA) and regulatory interactions in early development.
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