Parexel Hiring for Regulatory Affairs Associate- Apply Online

Regulatory Affairs Associate

Primary Location: India, Bengaluru Additional Locations: India, RemoteJob ID R0000037270 Category Regulatory Affairs

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

About This Role

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