Regulatory Affairs Associate – Labelling | Remote Job at Parexel

Apply for the Regulatory Affairs Associate – Labelling position at Parexel (Remote, India). Qualification: 3-5 years of experience in regulatory affairs. Join a leading global pharma consultancy!

Opportunity: Regulatory Affairs Associate – Labelling at Parexel (Remote, India)

Are you an experienced Regulatory Affairs professional looking for a remote opportunity in a leading global pharmaceutical consultancy? Parexel is hiring a Regulatory Affairs Associate – Labelling to work with biopharmaceutical and medical device companies in navigating the evolving regulatory landscape.

Join us to make an impact on drug safety and compliance while working in a dynamic, flexible, and collaborative environment!

Job Overview

About Parexel

Parexel is a globally recognized clinical research and regulatory consulting firm specializing in helping companies bring innovative medicines to market efficiently. Our expert teams work across multiple therapeutic areas and product categories, ensuring compliance with international regulatory standards.

Role & Responsibilities

As a Regulatory Affairs Associate – Labelling, you will be responsible for:

• Managing safety and labelling changes with a direct impact on Product Information.
• Handling Company Core Data Sheet (CCDS) creation or updates to ensure regulatory compliance.
• Overseeing Change Control Assessments for regulatory submissions.
• Supporting Agency Workflows (AW) updates from a Regulatory Affairs perspective.
• Managing documentation and submissions using Veeva RIMS.
• Working on Centralized Products (EU/UK/CH/AU/NZ) and ensuring compliance with global labelling regulations.
• Utilizing TVT Tools for effective regulatory documentation and tracking.

Qualifications & Experience

• Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• Experience: 3-5 years in Regulatory Affairs (Labelling & Safety Changes) within the EU/UK/CH/AU/NZ regulatory framework.
• Technical Skills:
  • Strong understanding of CCDS updates and regulatory submissions.
  • Hands-on experience with Veeva RIMS (Regulatory Information Management System).
  • Knowledge of TVT tools is a plus.
  • Familiarity with centralized regulatory processes.
• Soft Skills: Excellent communication, analytical, and problem-solving abilities.
• Work Mode: 100% Remote (India).

How to Apply

Interested candidates can apply through the Parexel career portal:
🔗 Apply Now

📢 Don’t miss this opportunity to be part of a global leader in regulatory consulting!

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