When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Regulatory Affairs Associate
2 to 5 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.
Review dossier, submit dossier, negotiate with HA on approval.
Work with local Regulatory, medical, marketing and market access to support impact of changes