1. team members through challenging regulatory processes.
2. Regulatory Documentation: Prepare and review essential regulatory documents such as Chemistry, Manufacturing, Controls (CMC), and Marketing Authorization Transfers.
3. Client Engagement: Build strong relationships with clients, discussing complex regulatory issues, and providing expert guidance on regulatory compliance.
4. Subject Matter Expert (SME): Serve as the go-to expert in regulatory matters, including lifecycle maintenance, labeling, and publishing.
5. Budget Management: Oversee project scope, deliverables, and budget management to ensure smooth project execution.
6. Guidance and Training: Mentor junior colleagues and contribute to the development of their technical regulatory skills.
7. Client Presentations: Represent IQVIA in client meetings, including bid defense, where you will explain regulatory strategies and the company’s regulatory processes.
8. Training Delivery: Conduct small-group regulatory training sessions within the organization, enhancing team knowledge and capabilities.

Qualifications

• Educational Background: A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Experience: 5 to 6 years of hands-on experience in regulatory affairs, particularly in Chemistry, Manufacturing, Controls, and Lifecycle Maintenance.
• Industry Knowledge: A deep understanding of regulatory standards and procedures within the pharmaceutical or healthcare sectors.

Skills

1. Regulatory Affairs Expertise: In-depth knowledge of regulatory documentation, procedures, and industry standards is essential.
2. Technical Writing: Strong ability to prepare and review detailed regulatory documents with precision.
3. Client Relations: A proven ability to build and maintain relationships with clients while handling complex regulatory discussions.
4. Project Management: Experience in managing project scope, deliverables, and budget, ensuring timely and efficient execution.
5. Leadership & Mentorship: Capable of leading teams and providing guidance to junior colleagues, helping them grow professionally.

How to Apply

Email your resume and cover letter directly to the hiring manager, Subhro Banerjee, at subhro.banerjee@iqvia.com.