Senior Regulatory Affairs Associate- CMC Biologics

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.

Key Responsibilities

• Manage the lifecycle of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies), across various global markets

• Prepare and deliver regulatory submissions, including authoring and reviewing CMC components of Marketing Authorization Applications (MAAs) and Variations for different types of medicinal products

• Handle CMC-related Health Authority queries and author responses to regulatory requests with accuracy and strategic insight

• Conduct regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with applicable regulatory requirements

• Author CMC components of Annual Reports, renewals, and GMP-related submissions, including site registrations and regulatory documentation

• Prepare regulatory impact assessments for change controls and identify documentation required for EU, US, and other market submissions

• Execute and maintain submission delivery plans and submission content plans, providing proactive status updates to stakeholders

• Prepare, review, and submit safety variations to Health Authorities and perform post-approval CMC-related updates

• Author and maintain labeling content for the EU, US, Canada, and Australia/New Zealand markets based on Company Core Data Sheets and regulatory guidance

• Liaise closely with cross-functional teams and stakeholders to ensure alignment on product-related responsibilities and regulatory strategy

You'll thrive in this role if you bring:

• Strong expertise in regulatory affairs with deep knowledge of CMC, labeling, and post-approval management

• Comprehensive understanding of EU and US regulatory procedures, with knowledge of global regulatory frameworks across different markets

• Experience managing the lifecycle of approved biopharmaceutical products, including small molecules and biologics

• Proficiency with Regulatory Information Management Systems (RIMS) such as Veeva Vault

• Excellent written and verbal communication skills with the ability to collaborate across teams and with Health Authorities

• Strong attention to detail, organizational skills, and the ability to manage multiple submissions and regulatory timelines

• A strategic mindset with the ability to provide regulatory guidance and impact assessments

Required Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline

• 5+ years of experience in handling the lifecycle management of approved drug products, including small molecules and biologics, across various global markets

• Working knowledge of EU and US regulatory procedures, including post-approval requirements

• Strong understanding of regulatory frameworks and global pharmaceutical legislation, particularly CMC aspects within ICH countries

• Experience with Regulatory Information Management Systems (RIMS), such as Veeva Vault

• Excellent communication, organization, and problem-solving skills

Preferred Qualifications

• Master's degree in Pharmacy, Life Sciences, or a related discipline

• Experience in handling CMC-related Health Authority queries and authoring responses

• Knowledge of regulatory legislation in Rest of World (ROW) markets

• Familiarity with EU QRD template requirements and European Commission guidelines on excipients in medicinal products

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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