Regulatory Affairs Associate

3 weeks ago

Bengaluru, Karnataka, India Parexel Full time

Regulatory Affairs Associate

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.


• 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


• Knowledge of CTD guidelines

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