Senior Regulatory Affairs Associate- CMC Biologics
parexel· 1785 Parexel International India safety services Private Limited
About this role
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.
Senior Regulatory Affairs Associate -Biologics
- Relevant experience in handling the life-cycle management of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies), across various global markets.
- Good understanding of the regulatory framework, including regional trends, for different types of applications and procedures.
- Contribute to the preparation (including authoring, where relevant) and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and/or regional perspective.
- Working knowledge of EU and US regulatory procedures, including post-approval requirements. Knowledge of regulatory legislation in Rest of World (ROW) markets would be an added advantage.
- Experience in handling CMC-related Health Authority (HA) queries and authoring responses to HA requests.
- Strong understanding of regulatory frameworks, including regional trends, for various application types and procedures related to both small and large molecules across global markets, as well as knowledge of global pharmaceutical legislation and guidance, particularly regulatory CMC aspects within ICH countries.
- Experience in authoring and reviewing the CMC components of Marketing Authorization Applications (MAAs) and Variations for different types of medicinal products (oral and parenteral) filed in the EU through DCP, MRP, and National Procedures.
- Preparation of documentation for various variation procedures, including Super Grouping, Grouping, and Work-Sharing applications for Marketing Authorizations.
- Regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with applicable regulatory requirements.
- Author CMC components of Annual Reports, renewals (Modules 1, 2, and 3), and GMP-related submissions, including site registrations.
- Provide regulatory impact assessments for change controls and identify the documentation required for EU, US, and other market submissions.
- Liaise closely with cross-functional teams and stakeholders to ensure alignment on product-related responsibilities.
- Execute and maintain submission delivery plans and submission content plans, while proactively providing status updates to designated stakeholders.
- Prepare, review, and submit safety variations to Health Authorities and perform post-approval CMC-related updates.
- Working experience with Regulatory Information Management Systems (RIMS), such as Veeva Vault.
- Experience in authoring and maintaining labeling content for the EU, US, Canada, and Australia/New Zealand markets based on the Company Core Data Sheet (CCDS), PRAC recommendations, and CMDh recommendations.
- Familiarity with EU QRD template requirements and European Commission guidelines on excipients in medicinal products.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline.
- Master's degree preferred.
Frequently Asked Questions
Is the salary disclosed for the Senior Regulatory Affairs Associate- CMC Biologics position at parexel?
The salary for this Senior Regulatory Affairs Associate- CMC Biologics role at parexel is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Is the Senior Regulatory Affairs Associate- CMC Biologics job at parexel remote?
Yes, this Senior Regulatory Affairs Associate- CMC Biologics position at parexel is remote, with team members based in India-Bengaluru-Remote. You can work from home or anywhere in the supported regions.
Which team or department does the Senior Regulatory Affairs Associate- CMC Biologics at parexel belong to?
This Senior Regulatory Affairs Associate- CMC Biologics position is part of the 1785 Parexel International India safety services Private Limited department at parexel. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Regulatory Affairs Associate- CMC Biologics position at parexel?
Click the "Apply Now" button on this page. You will be redirected to parexel's official application portal hosted on workday where you can submit your application directly.
When was the Senior Regulatory Affairs Associate- CMC Biologics job at parexel posted?
This Senior Regulatory Affairs Associate- CMC Biologics position at parexel was posted on Jul 23, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Regulatory Affairs Associate- CMC Biologics
parexel
You'll be redirected to parexel's official application page on Workday.