Parexel hiring Regulatory Affairs Associate
We are hiring !! Regulatory Affairs Associate. CMC Skills.
Regulatory Affairs Associate-
Relevant 2 + 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:
o Submission delivery strategy
o Review of documents
o 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
Education:
- Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences
Be a part of an exciting, challenging, flexible, and rewarding work culture.
For your next opportunity visit: https://bit.ly/3NUnPqJ
