Parexel hiring Regulatory Affairs Associate Role in Hyderabad

Parexel Job Opportunity: Regulatory Affairs Associate

Are you passionate about regulatory affairs in the biopharmaceutical and medical device industry? Parexel is looking for a Regulatory Affairs Associate to join their team in Hyderabad, India. Learn more about this exciting opportunity below.

About Parexel

Parexel is a leading consulting firm that assists biopharmaceutical and medical device companies in navigating regulatory challenges effectively. As part of Parexel Consulting, you will contribute to developing and implementing regulatory strategies that accelerate product approvals and market access.

Job Details

• Job Title: Regulatory Affairs Associate
• Location: Hyderabad, India
• Job ID: R0000021383
• Category: Regulatory / Consulting

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

Qualifications and Skills

To succeed in this role, you should possess:

• 2 to 5 years of experience in Regulatory Affairs-CMC.
• Willingness to work in EU shifts.
• Strong understanding of regulatory frameworks and procedures.
• Excellent communication and relationship-building skills.
• Detail-oriented and results-driven mindset.
• Strategic thinking and problem-solving abilities.

How to Apply

If you are ready to take on this exciting challenge and contribute to regulatory excellence, apply now for the Regulatory Affairs Associate role at Parexel in Hyderabad.