PHARMAFull-time
Regulatory Affair Manager
MUMBAI (IN)HYBRIDPOSTED: 9/18/2026
PHARMAFull-time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE OVERVIEW
Regulatory Affairs Manager leading strategic and operational regulatory activities across product development, registration, launch, lifecycle management, and post-marketing. The role manages complex submissions, regulatory risks, health-authority interactions, compliance, and regulatory capability development.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead or participate as a regulatory expert in cross-functional teams throughout product development and lifecycle activities
- •Plan and manage complex global and regional regulatory submissions and health-authority responses
- •Advise senior management and business partners on regulatory strategy, risks, timelines, and compliance
- •Drive improvements in submission preparation, publishing, documentation quality, and regulatory compliance
- •Identify regulatory and operational risks and implement mitigation strategies
- •Build partnerships with Regulatory, R&D, Operations, Marketing, Manufacturing, health authorities, consortia, and vendors
- •Maintain accurate regulatory systems and records
- •Coach and mentor colleagues and drive adoption of new regulatory requirements, systems, technologies, and strategies
Reporting Hierarchy: Leads or participates in cross-functional and international teams and advises senior management and business partners; specific reporting manager and team size are not stated
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 10-12 years of experience in regulatory affairs or drug development within the pharmaceutical or related industry
- Detailed knowledge of global and regional drug regulatory approval processes and submission standards
- Proven project management and leadership experience with cross-functional and international teams
- Strong communication, negotiation, and collaboration skills
- Expertise in information and document management technology and submission tools
- Ability to identify, manage, and mitigate regulatory and operational risks
PREFERRED QUALIFICATIONS
- •Line or matrix management experience
- •Experience managing resource requirements for pivotal projects
- •Knowledge of AstraZeneca business processes and regulatory systems
- •Deep understanding of evolving regulatory environments and industry trends
REQUIRED VERIFIED SKILLS
Regulatory Affairs
Global Regulatory Strategy
Regional Regulatory Strategy
Regulatory Submissions
Health Authority Responses
Lifecycle Management
Regulatory Compliance
Regulatory Risk Management
Project Management
Submission Publishing
Document Management
Regulatory Intelligence
Regulatory Systems
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Lifelong learning, growth and development opportunities; inclusive and collaborative workplace; flexible working alongside an expectation of at least three office days per week on average; specific benefits are not detailed in the provided posting.
Salary is not disclosed in the provided posting; no compensation figures are inferred.
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global science-led, patient-focused biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines for serious diseases.
TEAM SIZE: 90,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
Culture: AstraZeneca emphasizes science, collaboration, inclusion, lifelong learning, growth, development, and flexible in-person working, with an average minimum of three office days per week.
EXPECTED CAREER ROADMAP
The role can progress toward Senior Regulatory Affairs leadership, Associate Director, Director, or broader global regulatory strategy and regulatory operations leadership positions, depending on organisational structure and performance.
APPLICATION ADVISORY
Emphasize 10-12 years of regulatory affairs or drug development experience; demonstrate ownership of complex global/regional submissions and health-authority interactions; highlight regulatory strategy, risk mitigation, project management, and international cross-functional leadership; showcase submission publishing and regulatory systems expertise; include experience with mentoring, regulatory intelligence, and process improvement.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.