Job Description

Vacancy for Regulatory Affairs Associate at Parexel 2023.

Organization	Parexel
Post Name	Regulatory Affairs Associate
Job Location	Hyderabad
Official Website	https://www.parexel.com/

Job Title/Position:

Regulatory Affairs Associate

Job vacancy for Pharmacy

Hyderabad

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: 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

Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Science

Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.

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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