Temporary Manager, CMC Regulatory Dossier Management I
About the Company
A dynamic biopharmaceutical company dedicated to the discovery, development, and commercialization of targeted therapies for cancer treatment. Our mission is to bring innovative oncology solutions to patients in need, and we are committed to maintaining the highest standards of regulatory excellence and scientific rigor in everything we do.
Position Overview
We are seeking a Temporary Manager for CMC Regulatory Dossier Management I to join our regulatory affairs team on a contract basis. In this specialized role, you will oversee the management and development of Chemistry, Manufacturing, and Controls (CMC) regulatory dossiers, ensuring compliance with regulatory requirements and supporting the advancement of our cancer therapeutics pipeline. This position offers the opportunity to contribute meaningfully to the regulatory strategy of innovative oncology treatments.
Key Responsibilities
– Manage and coordinate the development, organization, and maintenance of CMC regulatory dossiers
– Ensure regulatory compliance and adherence to applicable guidelines and standards
– Collaborate with cross-functional teams including chemistry, manufacturing, quality, and clinical groups to gather and integrate CMC information
– Prepare and review regulatory documentation for submission to health authorities
– Support regulatory submissions and respond to regulatory inquiries related to CMC matters
– Maintain detailed records and documentation in accordance with regulatory requirements
– Communicate regulatory updates and requirements to relevant stakeholders
Qualifications
– Demonstrated expertise in regulatory affairs, with specific experience in CMC regulatory matters
– Strong knowledge of pharmaceutical regulatory frameworks and submission requirements
– Proven experience managing regulatory dossiers and documentation
– Excellent organizational and project management skills
– Strong written and verbal communication abilities
– Ability to work effectively with cross-functional teams
– Professional judgment and attention to detail