Regulatory Affairs Associate
2 weeks ago
2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
- To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
o Submission delivery strategy
o Review of documents
o Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
- Liaise closely with cross-functional members with aligned product responsibilities.
- Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Authoring the dossier sections based on the changes to approved MAA
- Knowledge of change evaluation according to country guidelines
- Experience in managing lifecycle activities in the EU markets would be preferrable
- Knowledge of CTD guidelines
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