Senior CMC Regulatory Sciences Specialist
Job Description:
We are seeking a highly skilled Senior CMC Regulatory Sciences Specialist to join our team. The ideal candidate will have excellent written and verbal communication skills, with the ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail.
Key Responsibilities:
1. Document Development: Drafting and reviewing global CMC documents and sections for commercial biopharmaceutical regulatory submissions.
2. Coordination and Management: Handling and coordinating the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from regulatory agencies.
3. Collaboration and Partnership: Collaborating with functional area and cross-functional teams, contract manufacturing organizations, and global Regulatory partners.
Requirements:
* Excellent Communication Skills: Excellent written and verbal communication skills.
* Project Management Skills: Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail.
* Critical Thinking and Problem-Solving Skills: Strong skills in planning, critical thinking and problem-solving.