Regulatory Affairs Manager
Department: Regulatory Affairs General
Location: New Delhi, India
Division: IPDO
Job Type: Full-Time
Company Overview:
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company operating in 66 countries with a strong commitment to accelerating access to affordable and innovative medicines. Founded in 1984, Dr. Reddy’s focuses on sustainability, diversity, and delivering healthcare solutions with a purpose-driven and future-ready approach.
Job Summary:
We are seeking a dynamic, motivated, and experienced Regulatory Affairs professional to join our team in New Delhi. The ideal candidate should have 8-12 years of experience in Regulatory Affairs, with a deep understanding of Indian regulatory requirements including D&C Act, NDCTR, GMP, GCP, and DMR.
Roles & Responsibilities:
Liaise with Central Drugs Standard Control Organization (CDSCO), zonal, and state drug offices for obtaining necessary drug approvals to support Indian and emerging markets.
Manage relationships with CDSCO, IPC, NIB, NPPA, RCGM, and other regulatory bodies.
Review, submit, and follow up on applications/portfolios assigned, ensuring timely regulatory approvals.
Provide feedback to the Central Regulatory Affairs (RA) team based on daily interactions with authorities.
Handle, review, and approve artworks ensuring compliance with regulatory standards.
Track license validity and expiry, planning for timely renewals and post-approval commitments.
Support the RA team with necessary documentation for drug registration and maintenance.
Ensure compliance for approved products and products under filing, in line with new regulations.
Provide regulatory intelligence and track regulatory changes impacting the organization.
Update and maintain a centralized Management Information System (MIS) database for all related activities daily.
Maintain timelines for approvals, submissions, and SEC meeting inclusions.
Develop and implement regulatory strategies to support product development and lifecycle management.
Collaborate with cross-functional teams to ensure regulatory compliance during product development.
Prepare and review regulatory submissions for clinical trials and marketing authorizations.
Conduct regulatory risk assessments and develop mitigation strategies.
Participate in regulatory inspections and audits, ensuring thorough preparation and follow-up.
Qualifications:
Educational Qualification: B.Pharm / M.Pharm / Life Sciences Graduate or Postgraduate.
Experience: 8-12 years in Regulatory Affairs.
Skills & Attributes:
Technical Skills:
Deep understanding of GMP, Quality Systems, D&C Act, NDCTR, etc.
Knowledge of product development, manufacturing processes, intellectual property, and quality standards.
Strong grasp of Indian regulatory requirements and international regulatory guidelines (ICH, WHO).
Experience preparing and reviewing regulatory submissions for various product categories.
Knowledge of pharmacovigilance and post-marketing surveillance.
Proficiency in regulatory information management systems and databases.
Behavioral Skills:
Excellent communication and interpersonal skills.
Effective team player with good collaboration skills.
Strong influencing and negotiation abilities.
Analytical mindset with problem-solving capabilities.
High attention to detail and ability to handle multiple projects simultaneously.
Flexibility to adapt to changing regulatory and organizational priorities.
Additional Requirements:
Proficiency in Microsoft Office and regulatory-specific software.
Willingness to travel for regulatory meetings and inspections.
About the Department:
Integrated Product Development Organization (IPDO) at Dr. Reddy’s integrates deep scientific expertise and technology to develop innovative, accessible, and affordable therapies worldwide. With capabilities across API, Formulations, Clinical, Intellectual Property, and Regulatory Affairs, IPDO drives a portfolio of over 1,000 products and has a strong global footprint.
Benefits Offered:
Competitive benefits package including joining & relocation support, maternity & paternity benefits, learning & development opportunities, medical coverage, and life insurance.
Career growth support through personalized learning programs.
Work Culture:
Guided by the credo "Good Health Can’t Wait," Dr. Reddy’s fosters a culture of empathy, dynamism, and collaboration. With people at the center of its success, the company emphasizes individual capability, teamwork, and a shared value system to deliver healthcare solutions.
For more details, visit: Dr. Reddy’s Careers
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