Senior Regulatory Affairs Associate- CMC Biologics

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role

We are seeking a Senior Regulatory Affairs Associate - Biologics to join our team in a remote capacity at India. As a regulatory affairs professional, you will drive the lifecycle management of approved biopharmaceutical products, ensuring compliance with global regulatory requirements and advancing patient access to innovative treatments. This position plays a key role in regulatory strategy, submission management, and cross-functional collaboration across global markets. You'll contribute to the preparation and delivery of regulatory submissions, manage health authority interactions, and provide strategic guidance on regulatory pathways for small molecules and biologics. With opportunities to deepen your expertise in CMC (Chemistry, Manufacturing, and Controls), labeling, and post-approval management, you will influence critical regulatory decisions that shape product success. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory excellence, strategic problem-solving, and cross-functional collaboration. With diverse teams and continuous learning opportunities, the Senior Regulatory Affairs Associate can explore career paths and expand skills across global regulatory affairs and product lifecycle management.