PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post: Regulatory Affairs Associate
Job Description
Must have 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
• Experience in managing lifecycle activities in the EU markets would be preferrable
• Knowledge of CTD guidelines
Additional Information
Job ID : R0000012328
Location : Hyderabad
End Date : 20th September, 2023
