Senior Regulatory Affairs Associate- CMC Biologics
parexel · India-Bengaluru-Remote ·
- Work mode
- Remote
- Seniority
- Senior
- Category
- Legal
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.