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

* 5+ years experience in handling life cycle management of approved drug
products (small molecules as well as biologicals including Vaccines,
monoclonal antibodies) in various markets.
* Valuable 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
* Good 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 Authoriz

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