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