Senior Global CMC Strategy Lead
4 semanas atrás
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey.
We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions to help bring life-saving treatments to patients worldwide.
Sponsor: You will be dedicated to a global pharmaceutical/biotech leader in innovative drug development, helping to bring life-changing therapies to market.
Job Overview: As a Senior Global CMC Strategy Lead, you will play a pivotal role in overseeing and coordinating Regulatory CMC activities to support tech transfer projects across multiple countries.
You will work closely with production sites, regulatory authorities, and internal teams to ensure regulatory compliance and facilitate seamless project execution.
Main Responsibilities: Develop and implement comprehensive Global CMC strategies to meet diverse global requirements across production sites. Manage Regulatory CMC activities, including the preparation, submission, and management of CMC documentation for regulatory filings. Coordinate change notifications to ensure timely and accurate regulatory updates across global markets. Build strong relationships with internal and external stakeholders, including regulatory agencies, supply chain teams, and manufacturing sites. Support tech transfers by aligning Regulatory CMC activities with tech transfer processes, ensuring smooth transitions while maintaining compliance.
Requirements: Proven expertise in Regulatory CMC in a global environment, including regions such as Asia, LATAM, USA, and EU. Strong understanding of CMC regulatory requirements for pharmaceuticals, particularly solid dosage forms. Experience managing regulatory submissions and handling change control processes. Excellent communication and organizational skills to facilitate collaboration across cross-functional teams. Ability to manage complex projects and adapt plans to address unforeseen challenges. Estimated salary range: $120,000 - $180,000 per year.
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