Execution of global CMC Regulatory Submissions operational activities in support of pipeline programs (IMPD/CTA/IND), commercial programs such as Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, and Post- Approval changes to ensure continuous supply assurance, compliance submissions and process improvement are filed in a timely manner. Initiate and facilitate kick-off meetings, authoring of submission sections, review cycles, ensure content verification and traceability to source documentation. Operational activities in electronic systems like EDMS (Baxedge), Please Review, Premier (MS Project) to enable submission preparation and finalization by the SMEs and reviewers/approvers. Coordinate and confirm that all CMC Submission documents are submission ready for final publishing.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=11847010&SearchString=&StatesString=&jobseq=20&rowsperpage=30&divisions=&divisions2=
No comments:
Post a Comment