Lead Regulatory Affairs – Pharmaceutical & Clinical Development
Location: Mumbai, India
Job Type: Full-Time
Experience Required: 8–12 years in Regulatory Affairs, including people management
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases. With a strong presence in India and worldwide, AstraZeneca combines scientific innovation with patient-centered care to deliver therapies across oncology, cardiovascular, respiratory, immunology, and other therapeutic areas.
Role Overview
As Lead Regulatory Affairs, you will oversee regulatory strategy, compliance, and lifecycle management for assigned franchise(s) in India. You will drive regulatory approvals for new products, additional indications, and clinical trials, ensuring alignment with global and local regulations. This role requires in-depth knowledge of Indian regulatory frameworks, experience in innovative treatment modalities, and demonstrated leadership in cross-functional and international regulatory operations.
Key Responsibilities
Regulatory Strategy & Compliance
Develop and implement regulatory strategies for assigned franchise(s) from clinical development to post-approval lifecycle management.
Plan risk mitigation strategies to accelerate product approvals and ensure timely SEC (Safety, Efficacy, Compliance) preparedness.
Ensure complete compliance with Indian regulatory requirements and global standards, including post-approval commitments, labeling, site transfers, and biologicals.
Interpret new regulatory guidelines and assess their impact on ongoing projects.
Clinical Trials & Global Collaboration
Lead efforts to include India in global clinical trials, aligning with international RA teams.
Provide regulatory input across clinical development, innovative treatment modalities, and business development initiatives.
Serve as the Good Regulatory Practices (GRP) Lead, ensuring RA function adheres to internal quality systems.
Coordinate with cross-functional teams including QA, medical, supply chain, and business teams to align regulatory activities.
Leadership & People Management
Mentor and guide a team of 3–4 direct and indirect reports, assessing training and development needs.
Conduct periodic reviews of the RA function and contribute to talent development and succession planning.
Represent AstraZeneca in industry associations, contributing to regulatory policy advocacy and external engagement with regulatory authorities.
Audit & Quality Oversight
Act as RA lead during internal and external audits, ensuring corrective and preventive actions (CAPAs) are implemented.
Drive adherence to Good Regulatory Practices and support continuous improvement initiatives within the regulatory function.
Required Qualifications
Education: Bachelor’s degree in Pharmacy (B.Pharm)
Experience: 8–12 years in Regulatory Affairs, including 2–3 years of people management experience.
Strong understanding of Indian regulations and global regulatory frameworks.
Expertise in drug development, lifecycle management, and clinical trial regulatory submissions.
Excellent communication, collaboration, and leadership skills.
Preferred Qualifications:
Postgraduate degree in Pharmacy or related life sciences field.
Regulatory expertise in innovative treatment modalities.
Prior experience in Health Authority advocacy and regulatory policy shaping.
Why Join AstraZeneca
Work with a science-led, patient-focused organization driving global healthcare innovation.
Lead regulatory strategy and compliance for high-impact therapeutic areas.
Collaborate with cross-functional and international teams in a dynamic, inclusive environment.
Access to continuous learning, career development, and mentorship opportunities.
Join an organization committed to diversity, equity, and inclusion, empowering employees to thrive professionally and personally.
Apply now on ThePharmaDaily.com to become a Lead Regulatory Affairs Specialist at AstraZeneca and help shape regulatory strategy for innovative therapies with global impact.
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