
AstraZeneca, a globally renowned, science-driven biopharmaceutical leader, has officially announced a career opportunity for a Regulatory Affairs Manager based in Mumbai. Known for pioneering life-changing prescription medicines targeting the world’s most severe health challenges, the company is seeking an experienced professional to steer its regulatory strategies and drive compliance across product lifecycles.
Role Overview and Strategic Impact
The newly posted position sits at the intersection of product development, commercialization, and regulatory compliance. The incoming manager will act as a core regulatory expert within cross-functional teams, offering strategic guidance through every phase of a product’s lifecycle—from initial development and registration to launch and post-marketing maintenance.
Key responsibilities center on planning, managing, and delivering intricate global and regional regulatory submissions, health authority responses, and vital briefing materials. Additionally, the role demands close collaboration with senior leadership, product development units, and external stakeholders, including health authorities and industry vendors, to navigate complex compliance landscapes and mitigate operational risks.
Candidate Requirements and Qualifications
AstraZeneca is looking for candidates who bring deep industry expertise and robust leadership capabilities:
- Experience: 10 to 12 years of hands-on experience in regulatory affairs or drug development within the pharmaceutical or healthcare sector.
- Core Competencies: Comprehensive understanding of global and regional drug approval processes, submission standards, and health authority expectations. Strong project management skills, cross-functional leadership, negotiation abilities, and technical expertise in electronic submission tools.
- Preferred Attributes: Experience in line or matrix management, prior resource management for pivotal projects, and familiarity with AstraZeneca’s internal business processes.
Application Details
- Company: AstraZeneca
- Position: Regulatory Affair Manager
- Location: Mumbai, India
- Industry Type: Pharma / Healthcare / Clinical Research
- Application Deadline: 10th October 2026
