Job Title: Lead Regulatory Affairs
Company: AstraZeneca
Location: Mumbai, Delhi
Industry: Pharma / Healthcare / Clinical Research
Job ID: R-227508
Last Date to Apply: 30th July 2025
About AstraZeneca
AstraZeneca is a global, science-driven biopharmaceutical company committed to discovering, developing, and commercializing innovative prescription medicines. Focused on addressing some of the world’s most serious diseases, AstraZeneca stands at the forefront of medical advancements, ensuring patient-centric healthcare solutions. With a strong presence in over 100 countries, the company combines cutting-edge research with ethical business practices to improve global health outcomes.
Job Description: Lead Regulatory Affairs
Position Purpose
The Lead Regulatory Affairs role at AstraZeneca involves ensuring rapid and high-quality regulatory approvals while maintaining compliance with Indian and global regulations. The position requires managing regulatory submissions, artwork development, license lifecycle management, and coordination with health authorities.
Key Responsibilities
- Regulatory Acceleration: Develop and execute plans for swift approvals of assigned products.
- Dossier Submissions: Prepare and submit regulatory documents (NDAs, clinical trials, import licenses, site registrations).
- Artwork Management: Oversee India-specific artwork development and compliance.
- License Lifecycle Management: Handle renewals, revisions, and regulatory compliance updates.
- Stakeholder Coordination: Work with internal teams (Marketing, Medical, Legal, QA) and external agencies (CDSCO, NIB, IPC).
- Regulatory Intelligence: Monitor changes in regulations and ensure timely compliance.
- Promotional Material Review: Ensure all promotional content adheres to regulatory guidelines.
Minimum Requirements
- Education: M.Pharm / B.Pharm
- Experience: 10-14 years in India Regulatory Affairs with expertise in dossier compilation and Indian pharmaceutical regulations.
- Skills: Strong leadership, strategic planning, and stakeholder management.
Key Result Areas (KRAs)
- Regulatory Compliance: Ensure adherence to AZ policies, local laws, and industry standards.
- Efficient Approvals: Accelerate product approvals to facilitate timely market entry.
- Stakeholder Engagement: Build strong relationships with regulatory authorities and internal teams.
- Issue Management: Proactively address regulatory challenges and compliance risks.
- Quality Assurance: Maintain high standards in regulatory submissions and documentation.
How to Apply?
Interested candidates can apply through the AstraZeneca careers portal (Job ID: R-227508) before 30th July 2025. Ensure your resume highlights relevant regulatory experience in the pharmaceutical industry.
