Regulatory Affairs Associate

Regulatory Affairs Associate

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

 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

• Review dossier, submit dossier, negotiate with HA on approval.Work with local Regulatory, medical, marketing and market access to support impact of changes

Experience Level

Mid Level