Regulatory CMC Manager

2 days ago

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TFS HealthScience

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CRO • clinical trials • Scientific and Medical consulting • Contract Placement Solutions (staffing) • Regulatory Consulting

501 - 1000

Description

• Regulatory CMC Manager overseeing and coordinating CMC activities to support tech transfer projects. • Work closely with production sites, regulatory authorities, and internal teams to ensure compliance. • Manage preparation, submission, and management of CMC documentation for regulatory filings. • Build and maintain relationships with internal and external stakeholders, ensuring smooth project execution.

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.

Benefits

• Competitive compensation for your expertise and contributions. • Opportunity to lead high-impact global projects in a collaborative environment. • Flexibility to work remotely, offering a healthy work-life balance. • A chance to work with a global organization committed to innovation and patient-focused solutions.