Dr. Reddy’s Vacancy for Regulatory Associate Job -Apply Now
Regulatory Associate
- Hyderabad, Telangana, India
- Full-time
- Job Family: Regulatory Affairs
- Sub Job Family: Regulatory Affairs General
- Preferred type of working: On-Premise
- Years of Experience: 3 – 5
- Business unit: Biologics
Job Description
- 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
Qualifications
- 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
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