Regulatory Affairs Associate

5 days ago

Hyderabad, India Parexel Full time

Hyderabad, India

**Job ID** R0000012328

**Category** Regulatory / Consulting

**ABOUT THIS ROLE**:
**Regulatory Affairs Associate**

Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
- To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:

- Submission delivery strategy
- Review of documents
- 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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