Dr. Reddy’s is looking for a skilled Regulatory Affairs Analyst
Published onJune 29, 2026
Regulatory Affairs Analyst
Dr. Reddy's
M.Sc., M.Pharm, or Ph.D
Hyderabad
4-8 years
Job Posted Date:29/06/2026
Job Overview
Dr. Reddy’s is looking for a skilled Regulatory Affairs Analyst with experience in managing regulatory submissions across the US, Europe, and Canadian markets. The ideal candidate will have practical exposure to parenteral dosage forms and a solid understanding of international regulatory standards. This role involves the preparation of regulatory documentation, collaboration with cross-functional teams, and ensuring compliance throughout all stages of the product lifecycle.
Key Responsibilities
- Prepare and review regulatory submissions, including US ANDAs, 505(b)(2) applications, and dossiers for Europe and Canada.
- Draft and manage responses to regulatory queries and deficiency letters.
- Develop regulatory strategy documents, briefing packages, controlled correspondences, labeling, and artwork for submissions.
- Work closely with internal departments such as R&D, Analytical R&D, Supply Chain, Quality, and Intellectual Property teams.
- Collaborate with external partners, including Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).
- Identify regulatory risks and provide strategic recommendations during product development and submission activities.
- Support commercial product launches by reviewing manufacturing documents, specifications, analytical methods, stability protocols, and validation documentation.
- Coordinate with the eCTD publishing team to ensure timely and compliant electronic submissions.
Required Qualifications
Master's degree in Pharmacy (M.Pharm), M.Sc., or Ph.D. in a relevant discipline.
4–8 years of experience in pharmaceutical Regulatory Affairs.
Experience handling regulatory submissions for the US, European Union, and/or Canada.
Required Skills
Strong knowledge of FDA, European, and Health Canada regulatory requirements.
Good understanding of ICH guidelines and international pharmacopeias.
Experience with parenteral dosage forms and pharmaceutical product development.
Knowledge of manufacturing processes, quality systems, and intellectual property considerations.
Familiarity with eCTD submissions and regulatory documentation.
Preferred Competencies
Excellent written and verbal communication skills.
Strong analytical and problem-solving abilities.
Effective planning, organization, and time management.
Ability to work collaboratively with cross-functional teams.
Self-motivated, quick learner, and capable of managing multiple priorities.
Location: Hyderabad
Department: Regulatory Affairs – IPDO
Experience: 4–8 Years
Qualification: M.Sc., M.Pharm, or Ph.D.