Regulatory Affairs Associate

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:

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 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