Parexel
Website:
parexel.com
Job details:
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
- Experience in managing lifecycle activities in the EU markets would be preferrable
- Review dossier, submit dossier, negotiate with HA on approval.Work with local Regulatory, medical, marketing and market access to support impact of changes
Click on Apply to know more.