Are you passionate about advancing global healthcare through regulatory expertise? Dr. Reddy’s Laboratories Ltd., a leading multinational pharmaceutical company, is seeking a skilled Regulatory Affairs Analyst to join our Hyderabad team. With a legacy of innovation since 1984, we are committed to accelerating access to affordable medicines, serving over 1.5 billion patients by 2030. This full-time, on-premise role in our Integrated Product Development Organization (IPDO) offers a dynamic opportunity to contribute to regulatory strategy and product launches. If you have 3-6 years of experience and a knack for navigating complex regulatory landscapes, apply today to be part of our mission: Good Health Can’t Wait.
Key Responsibilities
- Prepare and Review Regulatory Documents: Develop and review US ANDAs, 505(b)(2), EU, and Canada dossiers for parenteral products, ensuring compliance with regulatory guidelines.
- Handle Deficiency Responses: Draft and review responses to regulatory deficiencies, including controlled correspondences and briefing books.
- Collaborate with Stakeholders: Work with internal teams (R&D, AR&D, SCM, FTO, CTO) and external partners (CMO, CRO) to review documents and provide strategic inputs.
- Support Commercial Launches: Assist the commercial launch team by evaluating batch records, specifications, analytical methods, stability protocols, and PVPs.
- Ensure eCTD Compliance: Coordinate with the eCTD/labeling team to ensure dossiers meet regulatory standards for filing.
- Identify and Resolve Issues: Proactively identify open issues during product development, ANDA filing, and deficiency responses in collaboration with team leads.
Qualifications
- Education: M. Pharm, M.Sc, or PhD in a relevant field.
- Experience: 3-6 years in regulatory affairs, preferably with parenteral products.
- Skills:
- Strong written and oral communication skills.
- Self-starter with a proactive, go-getter attitude.
- Team player with excellent interpersonal and networking skills.
- Quick learner, able to prioritize and manage complex information.
- High proficiency in regulatory strategy and documentation.
Benefits
- Global Impact: Contribute to Dr. Reddy’s mission to serve 1.5 billion patients by 2030.
- Inclusive Workplace: Join an equal opportunity employer committed to diversity and free from discrimination.
- Career Growth: Work in a purpose-driven, future-ready environment with opportunities for professional development.
- Sustainability Focus: Be part of a company prioritizing people, planet, and purpose.
- Competitive Compensation: Earn a salary range of INR 8,00,000–12,00,000 per annum, based on experience.
How to Apply
Ready to make a difference in global healthcare? Submit your resume and cover letter via the Dr. Reddy’s careers portal at Pharmabharat.com. Ensure your application highlights your regulatory affairs experience and alignment with our mission. Applications are reviewed on a rolling basis, with a deadline of November 13, 2025. For queries, contact our HR team through the portal.
FAQs
Q: What is the work environment like at Dr. Reddy’s?
A: Dr. Reddy’s fosters an inclusive, discrimination-free workplace that values diversity and merit. Our Hyderabad office offers a collaborative, purpose-driven environment focused on innovation and sustainability.
Q: What types of products will I work on as a Regulatory Affairs Analyst?
A: You will primarily focus on parenteral products, preparing and reviewing dossiers for markets like the US, EU, and Canada, ensuring compliance and supporting commercial launches.
