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 in India. In this role, you will contribute to the life-cycle management of approved drug products, including small molecules and biologics such as vaccines and monoclonal antibodies, across global markets. You will help prepare and deliver regulatory maintenance submissions, author and review Chemistry, Manufacturing, and Controls content, respond to Health Authority requests,



and support compliant post-approval activities across the EU, US, and other markets.

You will join a collaborative, growth-oriented environment where your regulatory expertise supports the continued availability and compliant maintenance of important therapies. Through increasingly complex submissions, cross-functional partnership, and exposure to multiple markets and procedures, you will have opportunities to deepen your regulatory knowledge and broaden your impact within clinical research and development.

Key Responsibilities

- Contribute to the preparation, authoring where relevant, and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and regional perspective.
- Author and review Chemistry, Manufacturing, and Controls components of Marketing Authorization Applications and variations for oral and parenteral medicinal products filed in the EU through Decentralised, Mutual Recognition, and National Procedures.
- Prepare documentation for variation procedures, including Super Grouping, Grouping, and Work-Sharing applications for Marketing Authorizations.
- Handle Chemistry, Manufacturing, and Controls related Health Authority queries and author responses to Health Authority requests.
- Review Drug Master Files, batch records, specifications, and stability data for compliance with applicable regulatory requirements.




- Author Chemistry, Manufacturing, and Controls components of Annual Reports, renewals across Modules 1, 2, and 3, and Valuable Manufacturing Practice related submissions, including site registrations.
- Provide regulatory impact assessments for change controls and identify documentation required for EU, US, and other market submissions.
- Prepare, review, and submit safety variations to Health Authorities and complete post-approval Chemistry, Manufacturing, and Controls updates.
- Execute and maintain submission delivery plans and submission content plans, and proactively provide status updates to designated stakeholders.
- Liaise closely with cross-functional teams and stakeholders to maintain alignment on product-related responsibilities.
- Author and maintain labeling content for the EU, US, Canada, and Australia and New Zealand markets based on the Company Core Data Sheet, Pharmacovigilance Risk Assessment Committee recommendations, and Coordination Group for Mutual Recognition and Decentralised Procedures recommendations.

Required Qualifications

- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline.
- 5+ years of experience in the life-cycle management of approved drug products, including small molecules and biologics such as vaccines and monoclonal antibodies, across global markets.
- Experience authoring and reviewing Chemistry, Manufacturing, and Controls components of Marketing Authorization Applications, variations, Annual Reports, renewals, and Good Manufacturing Practice related submissions.
- Experience handling Chemistry, Manufacturing, and Controls related Health Authority queries and authoring responses.

📌 Senior Regulatory Affairs Associate- CMC Biologics (India)
🏢 Parexel
📍 India