Dr. Reddy’s Vacancy for Regulatory Associate Job -Apply Now

Regulatory Associate

Preparation of applications and submission packages for various biologics/biosimilars regulatory submissions.
Authoring master and country specific dossier sections according to CTD module
Review of CMC technical documents required for submissions and ensure compliance with regulations and guidance
Updating and maintaining regulatory databases and ensure regulatory compliance
Familiar/Hands on with regulatory submission software’s including eCTD, RIMS etc
Assessment of the Change Controls against variation guidelines
Preparing, reviewing and submitting renewal documents/ renewal dossiers/ variations/responding to queries raised by Ministry of Health

Must have a master/professional degree in scientific discipline.
Must have 3+ years of hands-on relevant technical or regulatory experience within the biotechnology industry.
Proficiency in MS Office applications.
Detail-oriented, ability to learn, plan and work in a dynamic team environment.
Must have excellent communication (written and verbal), collaboration, and problem-solving skills