PAREXEL Hiring 2026: Senior Regulatory Affairs Consultant for Global Markets

PAREXEL, a premier global biopharmaceutical service provider, has opened applications for the role of Regulatory Affairs Consultant. With a reputation for excellence in contract research and medical communications, PAREXEL offers an expansive platform for professionals to manage complex drug development lifecycles across the world’s most stringent regulatory environments.

Role Profile: Regulatory Affairs Consultant

This is a high-level consulting role focused on the strategic and operational aspects of global regulatory submissions. The consultant will be responsible for navigating the diverse requirements of major international health authorities.

Key Responsibilities:

Global Lifecycle Management: Handle new registrations, renewals, and variations for a broad portfolio including Biologicals, Vaccines, Monoclonal Antibodies (mAbs), Recombinant Proteins, and Small Molecules.
Regional Expertise: Deliver regulatory submissions tailored to the specific standards of the US (FDA), EU (EMA), Japan (PMDA), Canada (Health Canada), Switzerland (Swissmedic), and Australia (TGA).
Dossier Authoring: Contribute to the preparation and review of Marketing Authorization Applications (MAA) and lifecycle variations.
Regulatory Intelligence: Monitor and interpret regional trends and global pharmaceutical legislation, particularly focusing on CMC (Chemistry, Manufacturing, and Controls) aspects under ICH guidelines.
Collaboration: Work independently while collaborating with global cross-functional teams to ensure timely market access for life-saving treatments.

Experience and Qualifications

PAREXEL is looking for seasoned experts who can lead complex projects with minimal supervision:

Experience: A minimum of 6+ years in Regulatory Affairs is mandatory.
Technical Domain: Proven track record in handling complex molecules (Biotech/Biologicals) is highly preferred.
Core Competencies: Strong understanding of ICH countries’ guidance, excellent communication skills, and the ability to manage multiple global procedures simultaneously.

Job Details & Application

Locations: Bengaluru, Hyderabad, Mumbai (Hybrid/Office-based depending on project needs).
Job ID: R0000037359.
How to Apply: Candidates should apply through the PAREXEL Careers Portal using the specific Job ID mentioned above.