Job Overview:
This role oversees the Chemistry, Manufacturing, and Controls aspects of commercial submissions, ensuring compliance with global regulatory standards.
Key Responsibilities:
* Drafting and reviewing global CMC documents
* Handling authoring, review, and finalization of CMC documents
* Collaborating with functional area teams
The ideal candidate has strong written and verbal communication skills, planning, critical thinking, and problem-solving abilities, as well as knowledge of drug development regulations.
Requirements:
Excellent written and verbal communication skills are required. The ideal candidate must have strong planning, critical thinking, and problem-solving abilities. Knowledge of drug development regulations is also necessary.
Benefits:
Working in this role offers opportunities for professional growth and development. Collaborating with cross-functional teams enhances skill sets and expands career horizons.