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
Relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience,



increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
Working knowledge of EU/US regulatory procedures including post approval requirements.
Experience in handling CMC related health authority queries, and author responses to HA requests
Valuable understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
Preparation of documentation for different types of Variation procedures like Super Grouping,
Grouping and Work-sharing to the Marketing Authorizations.
Regulatory re

📌 Senior Regulatory Affairs Associate (Bengaluru)
🏢 Parexel
📍 Bengaluru