Vacancy Description
Responsibilities:
Requirements:
- Responsible for managing and compiling CMC sections of marketed product variations.
- Partner with RA CMC Project Leads and develop module 3 content and project timelines.
- Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Skills for running review meetings for submission documents.
- Understand CMC expectations including CTD content, structural and formatting requirements.
- Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
Requirements:
- Bachelor's degree in science 4 years pharmaceutical. 1-2 years cross functional project management...
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