
CMC Regulatory Specialist
1 day ago
We are looking for a skilled CMC Regulatory Specialist to join our team. As a key member of our organization, you will play a crucial role in ensuring the success of our global operations.
The CMC Regulatory Manager will be responsible for developing, maintaining, and improving processes and procedures related to CMC processes. This includes driving consistency across practices and procedures, facilitating communication across teams, and ensuring awareness of processes.
This is a great opportunity to grow your career as a Regulatory Affairs Professional in a dynamic and innovative environment.
About this RoleJob Summary:
- Develop and maintain standard operating procedures (SOPs), process documentation, or training programs
- Ensure consistent use of processes and tools across departments
- Drive continuous improvement of templates for presentations, timelines, trackers, and other tools
- Liaise with functions in GRAAS and Operations to ensure alignment
Key Responsibilities:
- Support new hire onboarding program
- Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness
- Drive consistency across Global CMC & Device Regulatory Affairs
- Develop and maintain training materials Global CMC & Device Regulatory Affairs
- Train staff on select departmental processes and procedures
Bachelor's degree or higher in Life Sciences, Engineering, or a related field
Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry
Working knowledge of Regulatory CMC processes and global submission requirements
BenefitsWe offer a competitive salary and benefits package
A dynamic and innovative work environment
Opportunities for growth and professional development
OthersWe are an equal opportunities employer
Please note that we do not accept applications from recruitment agencies
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