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Dr. Reddy’s Laboratories, a globally respected multinational pharmaceutical company, is hiring a Regulatory Associate / Regulatory Affairs Specialist for its Hyderabad location. This is an excellent opportunity for experienced regulatory professionals seeking to work in a compliance-driven, science-led organization with strong global exposure.
The role focuses on regulatory dossier preparation, lifecycle management, quality systems, and pharmacovigilance activities, supporting timely product approvals and regulatory compliance across global markets.
Key Responsibilities – Regulatory Associate
As a Regulatory Associate at Dr. Reddy’s Laboratories, you will be responsible for:
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- Preparation, review, and submission of regulatory dossiers to global health authorities
- Managing product lifecycle activities, including variations, renewals, and amendments
- Ensuring compliance with FDA, EMA, and EM guidelines
- Supporting quality management systems (QMS) and SOP development
- Coordinating pharmacovigilance (PV) activities in alignment with regulatory requirements
- Supporting internal and external regulatory audits
- Implementing and tracking CAPA (Corrective and Preventive Actions)
- Conducting and participating in regulatory and compliance trainings
- Cross-functional collaboration with QA, PV, manufacturing, and global regulatory teams
Qualifications & Experience Required
Educational Qualification
- M.Pharm / MSc / Industrial Pharmacy
- Registered Pharmacy professional license holder preferred
Experience
- 4 to 8 years of hands-on experience in Regulatory Affairs
- Prior exposure to Quality Assurance (QA) and Pharmacovigilance (PV) is highly desirable
Skills & Competencies
- Strong working knowledge of FDA, EMA, and EM regulations
- Excellent written and spoken English
- Proficiency in MS Excel, Google Applications, and regulatory documentation tools
- High attention to detail with the ability to multitask and meet tight deadlines
- Strong interpersonal and stakeholder management skills
Salary & Benefits (Indicative)
- Salary Range: ₹6,00,000 – ₹12,00,000 per annum (CTC), depending on experience
- On-site full-time role with a leading global pharmaceutical company
- Exposure to international regulatory submissions
- Inclusive and equal-opportunity work culture
- Career growth in regulatory strategy, lifecycle management, and compliance leadership
Job Location
📍 Hyderabad, Telangana, India
Work Mode: On-site | Full-time
How to Apply
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