Lead Regulatory Affairs Job at AstraZeneca India
Looking to lead regulatory strategy in a global biopharmaceutical giant? AstraZeneca India is hiring a Lead Regulatory Affairs professional to manage regulatory activities from clinical development to lifecycle maintenance. This Regulatory Affairs Job role is ideal for experienced regulatory professionals who want to influence policy, accelerate approvals, and shape access to innovative medicines in India. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
- Job Role: Lead Regulatory Affairs
- Location: Bengaluru / Chennai
About the Company
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines for serious diseases. With over 45 years of presence in India, AstraZeneca continues to invest in affordable, sustainable, and cutting-edge healthcare solutions while empowering employees to grow and innovate. This Regulatory Affairs Job role plays a significant role in the company.
Educational Requirements
Essential
-
Pharmacy graduate
Desirable
-
Postgraduate qualification in Pharmacy
Key Responsibilities
- Lead regulatory affairs for one or more franchises from clinical development to lifecycle management
- Develop and implement regulatory strategies and risk mitigation plans for accelerated approvals
- Ensure India’s inclusion in global clinical trials through proactive regulatory engagement
- Maintain ~100% regulatory compliance across post-approval commitments, labeling, site transfers, and biologics
- Act as Marketing Company (MC) Regulatory Lead for assigned franchises
- Drive SEC preparedness in collaboration with medical teams
- Lead internal and external regulatory audits, ensuring CAPAs are implemented
- Act as GRP Lead, ensuring compliance with Good Regulatory Practices
- Oversee regulatory intelligence and assess the impact of new guidelines
- Support business development and regulatory policy advocacy initiatives
- Collaborate with QA, Medical, Supply Chain, Business, and International RA teams
- Manage and develop regulatory team members (3–4 direct/indirect reports)
Skills Required
- Strong expertise in Indian regulatory regulations
- Experience in drug development and clinical trials
- Knowledge of innovative and advanced treatment modalities
- Regulatory strategy development and execution
- People management and leadership skills
- Cross-functional and global stakeholder collaboration
- Regulatory intelligence and policy advocacy experience
- Audit readiness and compliance management
- Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
