Regulatory Affairs Analyst – Global Lifecycle Management (LCM)
Location: Hyderabad, India
Department: Integrated Product Development Organisation (IPDO)
Function: Regulatory Affairs – Global Lifecycle Management
Employment Type: Full-Time
Company: Dr. Reddy’s Laboratories Ltd.
About the Company
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical organization committed to accelerating access to affordable and innovative medicines worldwide. Established in 1984, the company now operates across 66 countries with strong capabilities in API, formulations, clinical research, intellectual property, and regulatory affairs.
Driven by science, innovation, and sustainability, Dr. Reddy’s aims to reach over 1.5 billion patients globally by 2030. The organization fosters a diverse, inclusive, and performance-oriented work culture grounded in integrity, compliance, and equal opportunity employment practices.
Role Overview
We are seeking an experienced Regulatory Affairs Analyst – Global Lifecycle Management (LCM) to manage post-approval regulatory activities across multiple international markets, with a strong focus on Europe.
This role plays a critical part in ensuring continuous regulatory compliance of marketed pharmaceutical products through timely lifecycle submissions, variations, renewals, and maintenance activities. The position requires close collaboration with global health authorities, manufacturing sites, CMOs, and cross-functional stakeholders.
Key Responsibilities
Global Lifecycle Management
Manage post-approval regulatory submissions including variations (Type IA, IB, II), renewals, notifications, and administrative updates across EU, UK, and Rest of World (RoW) markets.
Prepare, review, and submit Module 1 and CMC variation documentation.
Handle product information updates including SmPC, PIL, labeling content, and artwork compliance reviews.
Monitor submission timelines and ensure timely approvals from regulatory agencies.
Regulatory Authority Engagement
Interface directly with EU National Competent Authorities (NCAs), MHRA, and other global regulatory bodies.
Manage post-approval deficiencies and regulatory queries with timely and accurate responses.
Maintain strong professional relationships with regulatory stakeholders and health authorities.
Compliance & Strategy
Provide regulatory guidance and strategy for lifecycle changes to CMOs and internal cross-functional teams.
Support manufacturing sites during audits, inspections, and regulatory compliance reviews.
Maintain regulatory databases, tracking systems, and submission logs.
Contribute to SOP creation and revision related to lifecycle management.
Stay updated on evolving global post-approval regulatory requirements and industry standards.
Educational Qualification
M.Sc. or M.Pharm in a relevant discipline (Pharmaceutical Sciences, Regulatory Affairs, or Life Sciences).
Experience Required
8–12 years of hands-on experience in Regulatory Affairs.
Strong experience in European Lifecycle Management activities.
Demonstrated expertise in post-approval submissions and CMC variations for EU and global markets.
Core Competencies & Skills
Strong knowledge of EMA guidelines and European regulatory frameworks.
Experience handling global variations, renewals, and label updates.
Proficiency in regulatory documentation preparation (Module 1 and CMC).
Excellent written and verbal communication skills in English.
Strong stakeholder management and cross-functional collaboration abilities.
High attention to detail and ability to manage multiple deadlines.
Proficiency in MS Excel and Google applications.
About the Integrated Product Development Organisation (IPDO)
The IPDO integrates deep scientific expertise with advanced technology platforms to develop innovative and affordable therapies. With end-to-end capabilities across APIs, formulations, clinical research, intellectual property, and regulatory affairs, the department supports over 55 global markets including the USA, Canada, Europe, China, LATAM, ASEAN, and emerging regions.
Why Consider This Opportunity?
This role offers exposure to global regulatory strategy, European lifecycle management, and cross-market compliance leadership within a leading multinational pharmaceutical company. It is ideal for experienced regulatory professionals looking to expand their expertise in global post-approval regulatory operations and lifecycle strategy management.
Explore more verified global pharmaceutical, biotech, and regulatory affairs jobs on ThePharmaDaily.com.
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