Regulatory Affairs Manager
ROLE OVERVIEW
AstraZeneca is seeking a Regulatory Affairs Manager in Mumbai to lead complex regulatory strategies for its innovative biopharmaceutical portfolio. This senior role sits at the intersection of science, compliance and commercial delivery, shaping submissions, lifecycle management and health-authority interactions across global and regional markets. The position is critical to accelerating patient access to medicines, ensuring filings are right first time and maintaining AstraZeneca’s reputation with regulators. You will advise cross-functional teams, mitigate regulatory risks and champion process improvements in a company known for scientific leadership. For an experienced regulatory professional, this is a high-visibility opportunity to influence pipeline decisions, mentor talent and work with global stakeholders. It offers a rare blend of strategic ownership, operational depth and career-defining exposure within one of the world’s leading patient-focused pharmaceutical companies.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead regulatory strategy and operational support for product development, registration, launch, lifecycle management, and post-marketing activities across assigned markets.
- •Plan, author, and deliver complex global/regional submissions, briefing documents, health-authority responses, and maintenance filings within agreed timelines.
- •Advise senior management, development teams, and business partners on regulatory pathways, project risks, timelines, and compliance obligations.
- •Drive continuous improvement in submission preparation, electronic/paper publishing, documentation quality, and adherence to local and global standards.
- •Identify complex regulatory risks, propose mitigation strategies, and resolve operational/strategic challenges efficiently.
- •Build effective partnerships with internal Regulatory, R&D, Operations, Marketing, Manufacturing teams and external health authorities, consortia, vendors.
- •Maintain department systems and records to accurately reflect regulatory statuses, submissions, and compliance expectations.
- •Coach and mentor colleagues, share regulatory intelligence, and support development of team capabilities and high-performance culture.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s or master’s degree in pharmacy, pharmaceutical sciences, life sciences, medicine, or related field (B.Pharm, M.Pharm, PharmD, MSc, MBBS, MD).
- 10–12 years of regulatory affairs or drug development experience in pharmaceutical or related industry.
- Detailed knowledge of global/regional drug regulatory approval processes, submission standards, and health authority requirements.
- Proven project management and leadership experience with cross-functional and international teams.
- Strong communication, negotiation, and collaborative abilities across functions and cultures.
- Expertise in information/document management technology and electronic/paper submission tools.
- Ability to identify, manage, and mitigate regulatory and operational risks.
PREFERRED QUALIFICATIONS
- •Line or matrix management experience
- •Resource management for pivotal projects
- •Knowledge of AstraZeneca business, processes, and regulatory systems
- •Deep understanding of evolving regulatory environment and industry trends
- •Experience with new regulatory systems and technologies
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.