Regulatory Affairs Associate
Primary Location: India, Bengaluru Additional Locations: India, Remote 求人ID R0000037267 Category Regulatory / ConsultingAbout this Role
Regulatory Affairs Associate
Relevant 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.
• To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
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
• Review dossier, submit dossier, negotiate with HA on approval.Work with local Regulatory, medical, marketing and market access to support impact of changes
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