Global CMC Regulatory Associate

Eli Lilly And Company

1 - 4 years

15 - 19 Lacs

bengaluru

Posted:17 hours ago| Platform:

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Skills Required

supply chain publishing pharma pharmacy project management clinical trials cmc healthcare operations product support

Work Mode

Work from Office

Job Type

Full Time

Job Description

Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
Implement and in some cases interpret global regulations and guidance s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Regional Submission Associate, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.
Partner with Regional Submission Associate to align on submission strategies and timeline for deliverables and manage communications between Regional Submission Associate, GRA-CMC scientists, RD&E specialists and Quality/Regulatory representatives.

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