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Pharmacovigilance (PV) Regulatory Affairs Jobs at Dr. Reddy’s Labs

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Dr. Reddy’s Labs

B.Pharm, M.Pharm, M.Sc, or PhD in Pharmaceutical Sciences

Hyderabad

6 - 12 Years

Verified Job

Online Application
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Dr. Reddy’s Laboratories is a globally recognized multinational pharmaceutical company committed to accelerating access to affordable and innovative medicines. With a workforce of over 24,000 employees, Dr. Reddy’s operates across 66 countries, focusing on research, development, and manufacturing of high-quality pharmaceuticals.

Founded in 1984, the company has grown into a leader in the industry, driven by deep science, sustainability, and strong corporate governance. Their mission is to reach 1.5 billion+ patients by 2030 while maintaining ethical practices and fostering diversity and inclusion in the workplace.

Current Job Openings

1. Pharmacovigilance (PV) Specialist – ROW Market

Department: Global Manufacturing Organisation (GMO)
Job Family: Medical Affairs & Pharmacovigilance
Work Type: On-Premise

Job Description:

The PV Specialist will support pharmacovigilance activities for the Rest of World (ROW) market, ensuring compliance with regulatory requirements. The role involves:

  • Updating local and core PSMFs (Pharmacovigilance System Master Files).
  • Managing Safety Data Exchange Agreements (SDEAs) with partners.
  • Conducting signal detection and maintaining the Eudravigilance database.
  • Handling Risk Management Plans (RMPs) and regulatory variations.
  • Ensuring compliance for aggregate reports (PSURs, PSUSAs).
  • Supporting audits, inspections, and CAPA (Corrective and Preventive Actions).
  • Collaborating with cross-functional teams and vendors.

Qualifications & Skills:

  • Bachelor’s/Master’s degree in Pharmacy or Life Sciences.
  • 6-12 years of experience in pharmacovigilance, with at least 3 years in a pharmaceutical company.
  • Strong knowledge of global PV regulations (ROW markets).
  • Proficiency in Microsoft Office (Excel, PowerPoint).
  • Excellent communication, organizational, and multitasking skills.

2. Regulatory Affairs Specialist (Parenteral Products)

Department: IPDO (Integrated Product Development Organization)
Job Family: Regulatory Affairs
Work Type: On-Premise

Job Description:

The Regulatory Affairs Specialist will focus on US, EU, and Canada submissions for Parenteral (Injectable) products. Key responsibilities include:

  • Preparing and reviewing US ANDAs, 505(b)(2), EU, and Canada dossiers.
  • Managing deficiency responses, labeling, and artwork reviews.
  • Coordinating with R&D, AR&D, CMOs, and CROs for regulatory strategies.
  • Supporting commercial launch activities (batch records, specifications, stability protocols).
  • Ensuring eCTD compliance for regulatory submissions.

Qualifications & Skills:

  • M.Pharm, M.Sc, or PhD in Pharmaceutical Sciences.
  • 6-12 years of experience in Regulatory Affairs (Parenteral products preferred).
  • Expertise in US FDA, EMA, and Health Canada guidelines.
  • Strong project management and stakeholder coordination skills.

Why Join Dr. Reddy’s?

✅ Career Growth: Personalized learning & development programs.
✅ Work-Life Balance: Maternity/Paternity benefits, flexible policies.
✅ Health & Wellness: Comprehensive medical coverage for employees & families.
✅ Global Exposure: Work with teams across 66+ countries.

How to Apply?

Application Link For Pharmacovigilance (PV) Specialist – ROW Market

Application Link Regulatory Affairs Specialist

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