PAREXEL Regulatory Affairs Associate Recruitment – Apply Online
Parexel Regulatory Affairs Associate vacancy. Pharma Regulatory Affairs Associate job opening 2022. Pharma job opening 2022. Regulatory Affairs Associate vacancy. Pharmacy job opening. Candidates with degree in pharmacy may apply for the job vacancy at Parexel for the post of Regulatory Affairs Associate
Job Title: Regulatory Affairs Associate
Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences
Experience: Relevant 2 or 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 MA. Knowledge of change evaluation according to country guidelines Experience in managing lifecycle activities in the EU markets.
• Knowledge of CTD guidelines
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