Website AstraZeneca
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company dedicated to delivering innovative medicines that transform lives. With a strong presence in India and worldwide, AstraZeneca focuses on developing breakthrough treatments across oncology, cardiovascular, respiratory, and other therapeutic areas. Join a patient-centric organization committed to advancing healthcare through science and collaboration.
Position Summary
AstraZeneca is seeking an experienced Lead – Regulatory Affairs to join its Delhi, India office. This senior-level role will drive regulatory strategies, ensure compliance with Indian and global requirements, and work closely with authorities to accelerate access to life-changing medicines.
Key Responsibilities
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Regulatory Strategy & Execution: Develop and implement regulatory strategies for assigned therapeutic areas to enable timely product submissions and approvals.
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Authority Engagement: Liaise with CDSCO, IPC, NIB, MoH, ICMR, and other regulatory bodies to obtain approvals for new drugs, biologics, FDCs, and global clinical trials.
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Sample & Data Management: Oversee submission of samples to IPC/NIB, track testing outcomes, and manage inclusion of monographs in the Indian Pharmacopoeia.
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Regulatory Intelligence: Monitor competitor activities, generics, and market trends to provide actionable insights to internal teams.
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Cross-Functional Collaboration: Partner with business, medical, supply chain, and quality teams while mentoring junior regulatory associates.
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Policy Influence: Support leadership in shaping regulatory policies and representing AstraZeneca in industry forums.
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Compliance: Uphold AstraZeneca’s code of conduct and ensure adherence to local and global regulatory standards.
Candidate Profile
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Education: M.Pharm, B.Pharm, M.Sc, or B.Sc in Life Sciences or related discipline.
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Experience: 12–15 years of proven expertise in Indian regulatory affairs, with strong relationships across regulatory agencies.
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Core Competencies:
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Deep understanding of CDSCO and related Indian regulatory frameworks.
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Demonstrated success in securing approvals for new drugs, biologics, SNDs, and GCTs.
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Excellent communication, leadership, and stakeholder management skills.
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Ability to interpret evolving regulations and provide regulatory guidance.
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Why Join AstraZeneca
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Innovative Culture: Work in a dynamic, science-driven environment that encourages curiosity and learning.
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Global Impact: Contribute to the development of life-changing therapies for patients worldwide.
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Career Development: Access professional growth opportunities and global collaboration.
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Inclusive Workplace: Thrive in a diverse, supportive, and employee-focused organization.
Location
Delhi, India
Application Details
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Application Deadline: 18 September 2025
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How to Apply: Submit your application through the AstraZeneca Careers Page or via LinkedIn. Ensure your resume highlights relevant regulatory achievements and experience with Indian regulations.
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To apply for this job please visit careers.astrazeneca.com.