Parexel – Regulatory affairs Associate Vacancies

Parexel Hiring Regulatory affairs Associates at Bangalore Location. Interested & Eligible candidates apply now

About the Parexel : Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world.

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:
• 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
• Knowledge of CTD guidelines

Education:

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

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