Senior Regulatory Affairs Associate

4 weeks ago

Bengaluru, Karnataka, India Parexel Full time

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.

Skills

Preparation and submitting Clinical Trial Application and amendmentsHands on experience for CT-04 and Form CT-16 filling on SUGAM portalPreparation of SEC meeting documentationSound knowledge of New Drugs & Clinical Trials Rules_2019Handling queries raised by DCGI pertaining to regulatory submissionsComprehensive regulatory requirement for Investigational new drug, New drug and Product life cycle management.

Knowledge and Experience:6-9 years of experience in an industry-related environment

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