Are you an experienced regulatory affairs professional looking to make a significant impact in the pharmaceutical industry? AstraZeneca, a global leader in biopharmaceuticals, is hiring a Lead, Regulatory Affairs in Delhi, India. This director-level role offers a unique opportunity to shape regulatory strategies, liaise with key authorities like CDSCO and ICMR, and drive compliance for innovative medicines. Join a science-led, patient-focused organization committed to transforming healthcare and improving lives worldwide.
Key Responsibilities
As the Lead, Regulatory Affairs, you will spearhead regulatory strategies and ensure seamless compliance with Indian and global regulations. Your responsibilities include:
- Liaising with Regulatory Bodies: Engage with CDSCO, IPC, NIB, MoH, ICMR, and other health authorities to secure approvals for new drugs, biologics, FDCs, and global clinical trials (GCTs).
- Regulatory Strategy Development: Lead strategy formulation and execution for assigned therapeutic areas (TAs), ensuring timely submissions, query responses, and SEC meeting preparedness.
- Sample Submission and Follow-Up: Coordinate submission of test samples to IPC (non-biologicals) and NIB (biologicals), and follow up for testing reports and monograph inclusion in the Indian Pharmacopoeia.
- Regulatory Intelligence: Monitor competitor products and generics, providing actionable insights to the Regulatory Affairs team.
- Compliance and Ethics: Adhere to AstraZeneca’s code of conduct, local legislation, and global regulatory policies, maintaining confidentiality and disclosing potential breaches.
- Collaboration and Leadership: Work with cross-functional teams (business, medical, supply chain, QA) and guide junior RA associates.
- Policy Shaping: Support RA leadership in shaping regulatory policies and participate in industry association meetings.
Qualifications and Skills
To excel in this role, candidates must meet the following requirements:
- Education: M.Pharm, B.Pharm, M.Sc, or B.Sc.
- Experience: 12-15 years in India’s regulatory function, with established relationships with regulatory officials.
- Skills:
- In-depth knowledge of Indian regulatory frameworks (CDSCO, IPC, NIB, ICMR).
- Expertise in securing approvals for new drugs, SNDs, biologics, and GCTs.
- Strong communication and stakeholder management skills.
- Ability to interpret and implement new regulations and provide regulatory intelligence.
- Proven leadership and collaboration across cross-functional teams.
Why Join AstraZeneca?
AstraZeneca is more than a pharmaceutical company—it’s a global, science-driven organization dedicated to pushing the boundaries of healthcare. As a Lead, Regulatory Affairs, you’ll enjoy:
- Innovative Environment: Work in a dynamic, inclusive culture that fosters lifelong learning and entrepreneurial spirit.
- Impactful Role: Contribute to life-changing medicines for patients worldwide.
- Career Growth: Access opportunities for professional development and collaboration with global teams.
- Diverse and Inclusive Workplace: Join a team that values diversity, equality, and varied perspectives.
- Work-Life Balance: Benefit from AstraZeneca’s commitment to employee well-being and growth.
How to Apply
Ready to make a difference? Apply for the Lead, Regulatory Affairs position by September 18, 2025. Submit your application via the AstraZeneca careers page on LinkedIn. Ensure your resume highlights your regulatory experience and familiarity with Indian regulations. Referrals can double your chances of landing an interview, so connect with AstraZeneca employees in your network!
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FAQs
Q: What is the role of the Lead, Regulatory Affairs at AstraZeneca?
A: The Lead, Regulatory Affairs drives regulatory strategy, secures approvals from CDSCO and other bodies, ensures compliance, and provides regulatory intelligence for assigned therapeutic areas.
Q: What qualifications are required for this position?
A: Candidates need an M.Pharm, B.Pharm, M.Sc, or B.Sc with 12-15 years of experience in India’s regulatory function and strong knowledge of Indian regulations.
