Description
Responsibilities- Create and/or manage assembly of CMC documentation, for review by Regulatory Affairs as part of global regulatory submissions.
- Monitor CMC documentation for consistency with other regulatory documents on file, update documents as needed and communicate issues to Regulatory Affairs.
- Participate in project meetings to ensure consistency between development activities and regulatory CMC documentation.
- Contribute strategically to ensure Pharmaceutical Operations development activities are appropriately documented to support development history and regulatory submissions.
- Recommend and manage additional activities as needed to meet CMC requirements.
- Other activities as requested.
- Limited travel.
Education and Experience:
- B.S Degree in a science area
- 5-10 years experience in pharmaceutical development including creation of technical documents
- Prior experience writing and/or reviewing CMC documents and knowledge of regional regulatory requirements.
- Experience in a GMP environment
- Excellent organizational, computer, and documentation skills
- Experience in manufacturing, QC, QA, CMC submissions
- Excellent communication and interpersonal skills
To find out more about Real please visit www.realstaffing.com