Job Title: Executive – Regulatory Affairs
Location: Mumbai, India
Employment Type: Full-Time
Application Deadline: 18th December 2025
Job Requisition ID: R-240766
AstraZeneca is seeking a detail-oriented Executive – Regulatory Affairs to support regulatory processes for India operations. In this role, you will manage regulatory submissions, coordinate lifecycle management activities, and respond to Health Authority queries for commercial products and clinical trials. You will also ensure compliance with local legislation, global regulatory policies, and AstraZeneca’s internal standards.
This role provides exposure to regulatory dossier preparation, PSUR submissions, India-specific artwork compliance, and support for audits and CAPA actions. You will work closely with cross-functional teams to ensure timely and accurate regulatory operations.
Regulatory Submissions & Compliance
Prepare and submit regulatory dossiers for new drug applications, additional indications, GCT applications, site registrations, and import licenses.
Collate information and respond to Health Authority queries to facilitate regulatory approvals.
Ensure all licensing activities comply with local regulations, global policies, and AstraZeneca standards.
Maintain submission trackers and documentation for audit readiness.
Lifecycle Management
Manage product lifecycle activities including renewals, updates, and changes to product licenses.
Support regulatory intelligence initiatives by tracking and communicating updates on guidelines, circulars, and Health Authority notifications.
Prepare India-specific PSURs based on global PBRERs and respond to Health Authority questions.
Audit & Quality Support
Support internal and external audits by ensuring regulatory documentation is complete and audit-ready.
Assist in managing deviations and implementing Corrective and Preventive Actions (CAPAs).
Cross-Functional Collaboration
Collaborate with internal teams on regulatory and compliance matters.
Support regulatory aspects for product launches, testing, and lifecycle management initiatives.
Bachelor’s degree or equivalent professional qualification in a relevant field.
Experience in quality assurance or regulatory operations within a pharmaceutical environment.
Strong attention to detail, organizational skills, and ability to manage multiple priorities.
Desirable Qualifications & Experience
Postgraduate qualification in a relevant field.
Knowledge of local regulatory frameworks and Good Regulatory Practices.
Experience with Health Authority submissions and pharmacovigilance support.
At AstraZeneca, you will join an inclusive and collaborative environment where your work contributes to life-changing medicines and improved patient outcomes. The company promotes diversity, innovation, and career growth while encouraging employees to challenge the status quo and bring fresh ideas to the table.
You will gain exposure to regulatory affairs processes, cross-functional collaboration, and opportunities to develop professional expertise in a global biopharmaceutical organization.
How to Apply:
Submit your application by 18th December 2025 to join AstraZeneca’s Regulatory Affairs team in Mumbai and contribute to the company’s mission of transforming healthcare.
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