Beschreibung

In this role, you will coordinate CMC efforts for integration projects, ensuring compliance and efficiency. Your day-to-day responsibilities will include conducting assessments, resolving documentation gaps, and collaborating with senior leaders to optimize integration processes.

Anforderungen

• •Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences, Chemistry, or related scientific degree
• •8–10 years experience in Regulatory CMC, Quality Assurance or Technical Operations in the pharmaceutical industry
• •Experience in leading CMC strategy for integration efforts in M&A and tech transfers
• •Strong knowledge of ICH guidelines, GMP regulations and regulatory frameworks worldwide
• •Experience with global regulatory CMC submissions and GMP compliance across product lifecycle
• •Excellent communication and stakeholder management skills
• •Strategic thinking, high attention to detail and problem-solving skills
• •Excellent written and verbal communication skills in English

Aufgaben

• •Coordinate CMC efforts for integration projects
• •Conduct CMC due diligence assessments
• •Plan risk mitigation strategies
• •Identify and resolve gaps in CMC documentation
• •Ensure regulatory compliance during transitions
• •Integrate quality and manufacturing aspects of drug products
• •Develop CMC best practices and tools
• •Monitor timelines and deliverables for CMC workstreams
• •Manage complex integration workstreams as a primary business partner
• •Establish consistent processes and frameworks