Regulatory Science Expert
The role of a CMC Regulatory Sciences Specialist is pivotal in ensuring the Chemistry, Manufacturing, and Controls aspects of commercial submissions adhere to global regulatory standards.
This individual will possess excellent written and verbal communication skills, strong technical writing abilities, and an in-depth understanding of regulatory guidance and regulations.
Key Responsibilities Include:
* Preparing and reviewing global CMC documents and sections for commercial biopharmaceutical regulatory submissions
* Coordinating the authoring, review, and finalization of CMC documents and responses to CMC-related inquiries from regulatory agencies
* Collaborating with functional area and cross-functional teams, contract manufacturing organizations, and global Regulatory partners
For this position, a BS/BA/BEng in a scientific discipline and relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting are required.
Benefits of This Role:
* Contribute to the development of high-quality CMC documents that meet regulatory requirements
* Enhance your understanding of regulatory science and its applications in the biopharmaceutical industry
* Collaborate with experts in various fields to achieve common goals