Executive Regulatory Affairs Job at AstraZeneca for QA professionals with pharmaceutical manufacturing compliance and regulatory documentation experience.
The pharmaceutical industry continues to evolve at a rapid pace with rising regulatory scrutiny, stricter compliance requirements, and expanding global drug development programs. Regulatory Affairs professionals play a critical role in ensuring that life-saving medicines reach patients safely, compliantly, and without delays. With increasing complexity in regulatory submissions, audits, pharmacovigilance coordination, and lifecycle management, the demand for skilled Regulatory Affairs professionals has reached an all-time high in India. Executive Regulatory Affairs Job at AstraZeneca
In line with this industry demand, AstraZeneca, one of the world’s leading science-driven biopharmaceutical companies, has announced a new full-time vacancy for the position of Executive – Regulatory Affairs at its Mumbai, India location. This opportunity is ideal for professionals with experience in quality assurance and pharmaceutical regulatory compliance who are looking to build a long-term global career with a reputed multinational organization.
This position is open for immediate recruitment and the application deadline is December 18, 2025, making it a time-sensitive career opportunity for eligible candidates. Executive Regulatory Affairs Job at AstraZeneca
Key Highlights – Executive Regulatory Affairs Vacancy at AstraZeneca
- Hiring Organization: AstraZeneca
- Job Title: Executive – Regulatory Affairs
- Job Location: Mumbai, India
- Employment Type: Full-Time
- Job Requisition ID: R-240766
- Application Deadline: December 18, 2025
- Date Posted: December 10, 2025
- Industry: Pharmaceutical / Biopharmaceutical
- Core Domain: Regulatory Affairs and Quality Compliance
- Education Requirement: Degree in relevant discipline
- Experience Requirement: Pharmaceutical QA and Regulatory background
- Recruitment Type: Direct company payroll
About AstraZeneca – A Global Leader in Biopharmaceutical Innovation
AstraZeneca is a global, science-led, patient-focused biopharmaceutical organization committed to the discovery, development, and commercialization of prescription medicines for some of the world’s most serious health conditions. The company’s core therapeutic focus areas include oncology, cardiovascular, renal and metabolism, respiratory, immunology, and rare diseases. Executive Regulatory Affairs Job at AstraZeneca
With a strong presence across multiple continents, AstraZeneca operates with a mission to push the boundaries of science to deliver life-changing medicines that improve patient outcomes worldwide. Beyond being one of the world’s leading pharmaceutical companies, AstraZeneca is also recognized as a great place to work, offering an inclusive culture, continuous learning, and long-term professional growth.
Its Indian operations play a strategic role in regulatory submissions, clinical research coordination, quality assurance, manufacturing compliance, and market access. Executive Regulatory Affairs Job at AstraZeneca
Job Overview – Executive Regulatory Affairs Role
The Executive – Regulatory Affairs role is a critical support function within AstraZeneca’s India regulatory operations. The professional selected for this position will be responsible for managing and supporting multiple regulatory activities across product lifecycle management, safety reporting, licensing, audits, submissions, and compliance documentation. Executive Regulatory Affairs Job at AstraZeneca
This role requires strong knowledge of Indian regulatory processes, pharmaceutical quality systems, submission management, and regulatory intelligence, making it suitable for professionals with prior experience in quality assurance within pharmaceutical manufacturing environments. Executive Regulatory Affairs Job at AstraZeneca
Detailed Job Responsibilities and Core Functions
1. Health Authority Communication and Query Management
The Executive – Regulatory Affairs professional will:
- Collate regulatory information and respond to Health Authority queries
- Facilitate smooth regulatory communication
- Support regulatory approval processes through timely documentation responses
This function ensures uninterrupted regulatory progress for product approvals, amendments, and renewals.
2. Regulatory Submission Tracking and Documentation Control
The role involves:
- Maintaining and updating submission trackers
- Ensuring that all regulatory documentation remains accurate and current
- Supporting internal teams with real-time regulatory status updates
Effective documentation control is a core responsibility within this position.
3. India-Specific Artwork and Labeling Compliance
The candidate will support:
- Development of India-specific artworks
- Label compliance checks with CDSCO and local regulatory standards
- Coordination with cross-functional teams for timely artwork approvals
4. Regulatory Dossier Preparation and Submission
The Executive – Regulatory Affairs professional will assist in: Executive Regulatory Affairs Job at AstraZeneca
- Preparation and submission of regulatory dossiers for:
- New drug applications
- Additional indications
- Global clinical trial (GCT) applications
- Site registrations
- Import licenses
- Managing any additional regulatory submissions as assigned by the regulatory leadership team
5. Product Lifecycle Management Support
This role includes:
- Managing product renewals
- Coordinating amendments to product licenses
- Supporting post-approval regulatory activities throughout the product lifecycle
6. Management of India PSUR Submissions
Key safety reporting responsibilities include: Executive Regulatory Affairs Job at AstraZeneca
- Preparation of India-specific Periodic Safety Update Reports (PSURs) based on global PBRER
- Submission of PSURs within regulatory timelines
- Responding to Health Authority questions related to PSURs
7. Sample Testing and Regulatory Coordination
The individual will: Executive Regulatory Affairs Job at AstraZeneca
- Prepare and submit required documents to NIBL or CDTL
- Coordinate testing-related regulatory documentation
- Support internal teams with laboratory regulatory compliance
8. Issue Management and Regulatory Intelligence
The role includes:
- Managing regulatory issue escalations
- Providing current regulatory status to stakeholders
- Monitoring regulatory updates, circulars, public notices, and guidelines from Health Authority websites
- Circulating regulatory intelligence within internal regulatory teams for timely action
9. Audit Support, Deviations, and CAPA Management
This role supports:
- Internal and external regulatory audits
- Deviation management
- CAPA (Corrective and Preventive Action) implementation
- Continuous regulatory compliance improvement initiatives
10. Compliance with AstraZeneca Ethics and Governance
The Executive – Regulatory Affairs professional must: Executive Regulatory Affairs Job at AstraZeneca
- Adhere to AstraZeneca’s code of conduct and ethics standards
- Maintain full compliance with Global Regulatory Policies
- Follow corporate governance and audit requirements
- Ensure confidentiality of intellectual property, product data, and strategic regulatory decisions
- Proactively disclose any breach of compliance or conduct norms
Education, Qualifications, Skills, and Experience Requirements
Essential Qualifications
- Degree or equivalent professional qualification in a relevant pharmaceutical, life sciences, or regulatory discipline
- Prior experience in quality assurance within a pharmaceutical manufacturing environment
Desirable Qualification
- Postgraduate qualification in regulatory affairs, pharmaceutical sciences, quality assurance, or related disciplines
Key Skills Required for Regulatory Affairs Executive
- Strong understanding of Indian regulatory requirements
- Hands-on experience in pharmaceutical compliance operations
- Excellent documentation and record maintenance ability
- Analytical thinking and regulatory problem-solving skills
- Strong communication and stakeholder coordination ability
- Ability to work independently with minimal supervision
- High level of integrity, confidentiality, and professionalism
Location and Working Environment
- Job Location: Mumbai
- Work Type: Full-Time
- Industry Environment: Global biopharmaceutical regulatory operations
- Exposure: Regulatory submissions, safety reporting, audits, labeling, and lifecycle management
Mumbai offers excellent professional exposure in regulatory affairs due to its strong pharmaceutical manufacturing ecosystem and regulatory infrastructure. Executive Regulatory Affairs Job at AstraZeneca
Why Build Your Regulatory Career with AstraZeneca
AstraZeneca is globally recognized for its inclusive, innovative, and patient-centric work culture. Employees are encouraged to challenge scientific boundaries while maintaining the highest ethical and regulatory standards. Executive Regulatory Affairs Job at AstraZeneca
Career Growth Benefits
- Global exposure to international regulatory frameworks
- Continuous learning and regulatory upskilling opportunities
- Leadership development programs
- Internal job mobility across regulatory and quality domains
- Strong focus on lifelong learning and career development
Diversity, Inclusion, and Equal Opportunity Commitment
AstraZeneca is fully committed to: Executive Regulatory Affairs Job at AstraZeneca
- Equal opportunity employment
- Non-discrimination in recruitment and workplace policies
- Inclusive hiring across all qualified backgrounds
- Compliance with applicable employment laws and work authorization regulations
The company believes that a diverse and inclusive workforce results in stronger innovation and better patient outcomes. Executive Regulatory Affairs Job at AstraZeneca
Who Should Apply for This Executive Regulatory Affairs Job
This position is best suited for:
- Regulatory Affairs professionals with pharmaceutical QA experience
- Candidates working in licensing, submissions, and documentation control
- Professionals supporting audits, PSURs, CAPA, and regulatory intelligence
- Candidates seeking long-term global career growth in biopharmaceutical regulatory operations
How to Apply
Interested and eligible candidates must apply through the official AstraZeneca career portal before the application deadline. Executive Regulatory Affairs Job at AstraZeneca
Application Closing Date: December 18, 2025
Job Requisition ID: R-240766
Candidates are advised to:
- Keep updated regulatory experience details in their CV
- Highlight pharmaceutical QA and compliance exposure clearly
- Apply well before the closing date to avoid last-minute portal delays
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
