Work as Senior Regulatory Affairs Associate at PAREXEL

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Senior Regulatory Affairs Associate- CMC Biologics

Job Description
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

Candidate Profile
• 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
• 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

Additional Information
Qualification : Degree in Pharmacy, Life Sciences, Chemistry, Biotechnology
Job ID : R0000039988
Location : Bengaluru-Remote
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 10th December 2026