Regulatory Affairs Specialist at Dr. Reddy’s Laboratories in Hyderabad, India | Apply Now!
Are you a skilled regulatory affairs professional with a passion for making life-saving medicines accessible to the world? Dr. Reddy’s Laboratories Ltd. is looking for a Regulatory Affairs Specialist with expertise in parenteral product submissions to join its growing team in Hyderabad, India. If you’re ready to contribute to a mission-driven organization focused on innovation, compliance, and global health impact, this could be your perfect next move.
About the Company
Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical leader committed to delivering affordable and innovative medicines to patients worldwide. Established in 1984 with a bold vision and just 20 employees, the company has grown into a multinational powerhouse with a presence in 66 countries and a workforce of over 24,000 professionals. Guided by the purpose “Good Health Can’t Wait,” Dr. Reddy’s combines deep scientific expertise with sustainable business practices to improve healthcare access across the globe. The company is driving toward an ambitious goal: to serve over 1.5 billion patients by 2030 through the power of research, regulatory excellence, and global partnerships. Dr. Reddy’s is also deeply committed to diversity, equity, and inclusion, maintaining a workplace free
from discrimination and welcoming talent from all backgrounds. The company values transparency, ethical practices, and innovation as the cornerstones of its success.Job Details:
- Job Role: Regulatory Affairs Specialist
- Location: Hyderabad, Telangana, India
- Job Type: Full-time
- Job Family: Regulatory Affairs
- Sub Job Family: Regulatory Affairs General
- Preferred type of working: On-Premise
- Years of Experience: 6 – 12
- Business unit: IPDO
Job Description
- Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements.
- Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages.
- Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs.
- Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head.
- Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).
- In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines.
Qualifications
M. Pharm, M.Sc, PhD
Additional Information
Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.
Keywords: Regulatory Affairs Specialist, Dr Reddy’s Laboratories, Pharmaceutical, Multinational Company, Affordable Medicines
