Description
Duties include:- Coordinate the preparation and submission of US and International regulatory CMC submissions
- Develop and/or review regulatory documents to ensure quality submissions
- Create timelines and track deliverables to ensure on-time submissions
- Proactively identify issues and suggest appropriate regulatory strategies to mitigate risks
- Ensure consistent and appropriate communication within the department and with other functional areas
- Interface with global Regulatory partners, internal cross functional teams, and consultants
- Assist in the preparation for meetings with global regulatory authorities
- Attend relevant functional area and project team meetings
Bachelor's degree in biology or other life sciences discipline.
Please be in contact as soon as possible for this urgent position.
To find out more about Real please visit www.realstaffing.com