Regulatory Affairs Lead
AstraZeneca
Posted
4 days ago
Mumbai, Maharashtra, India
Onsite
INR 80K
Mid Level
Full Time
Sema Summary
Lead regulatory affairs for franchise products from clinical development to lifecycle maintenance. Ensure compliance with internal and external regulations while managing a team and overseeing collaboration with various departments.
About Company
AstraZeneca is a global, science-led biopharmaceutical company dedicated to the discovery and development of prescription medicines for serious diseases.
Core Requirements
- Graduate in Pharmacy
- Experience in regulatory affairs
- People management experience
- Knowledge of clinical trials
- Understanding of Indian regulations
Responsibilities
- Lead regulatory strategies for product approvals.
- Ensure 100% regulatory compliance.
- Manage people development within the team.
- Support business development projects.
- Facilitate cross-functional collaboration.
- Conduct audits related to regulatory affairs.
- Advocate for regulatory policy in industry associations.
Must Have skills
Job Keywords
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