Assistant Manager Regulatory Affairs Job at AstraZeneca in Mumbai for B.Pharm or M.Sc candidates with artwork management and regulatory experience.
Introduction
AstraZeneca has announced a job opportunity for the position of Assistant Manager – Regulatory Affairs at its Mumbai office. This role is designed for professionals with experience in pharmaceutical regulatory affairs, artwork management, and regulatory compliance.
The position focuses on managing product artwork development, labeling compliance, regulatory documentation, and coordination with cross-functional teams to ensure adherence to Indian regulatory guidelines and internal company standards.
Candidates with experience in Indian pharmaceutical labeling regulations and artwork approval processes will find this role particularly suitable for advancing their careers in regulatory affairs within a global pharmaceutical organization. Assistant Manager Regulatory Affairs Job at AstraZeneca
Job Overview
| Job Title | Assistant Manager – Regulatory Affairs |
|---|---|
| Company | AstraZeneca |
| Industry | Pharmaceutical / Regulatory Affairs |
| Job Location | Mumbai, India |
| Office Location | Mumbai Commerz |
| Employment Type | Full-Time |
| Department | Regulatory Affairs |
| Experience Required | 3 – 6 Years |
| Qualification | B.Pharm / M.Sc |
| Application Deadline | March 31, 2026 |
| Job Requisition ID | R-247747 |
Company Overview
AstraZeneca is a global science-driven biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for serious diseases. The organization operates across therapeutic areas such as oncology, cardiovascular diseases, respiratory medicine, and immunology.
The company collaborates with healthcare professionals, researchers, and regulatory authorities worldwide to ensure that medicines are safe, effective, and accessible to patients. AstraZeneca places strong emphasis on regulatory compliance, ethical practices, and scientific innovation.
Employees at AstraZeneca benefit from working in a collaborative environment that supports continuous learning, professional development, and global career opportunities. Assistant Manager Regulatory Affairs Job at AstraZeneca
Job Location & Employment Type
Location:
Mumbai, Maharashtra, India
Employment Type:
Full-Time
The role is based at AstraZeneca’s Mumbai Commerz office and will involve collaboration with both local and global regulatory teams. Assistant Manager Regulatory Affairs Job at AstraZeneca
Role Overview
The Assistant Manager – Regulatory Affairs will be responsible for managing pharmaceutical product artwork and labeling processes while ensuring compliance with Indian regulatory requirements.
The role requires coordination with multiple internal teams such as marketing, supply chain, medical affairs, legal, quality assurance, and global regulatory teams. The selected candidate will support product launches, lifecycle management activities, and regulatory compliance related to labeling and artwork. Assistant Manager Regulatory Affairs Job at AstraZeneca
Key Roles & Responsibilities
Artwork Management
One of the primary responsibilities of the role involves managing the development and approval of pharmaceutical product artwork.
Responsibilities include:
- Managing the artwork management system for product labels and packaging components
- Raising artwork requests with India-specific regulatory annotations
- Reviewing comments from global manufacturing sites
- Conducting peer reviews before approving final artwork files
- Ensuring artwork approval follows the company’s artwork approval checklist
This process ensures that product packaging and labeling comply with regulatory standards. Assistant Manager Regulatory Affairs Job at AstraZeneca
Coordination with Cross-Functional Teams
The Regulatory Affairs team works closely with multiple departments to ensure smooth regulatory operations.
Responsibilities include:
- Coordinating with packaging teams, supply chain teams, marketing departments, and legal teams
- Collaborating with global regulatory colleagues and manufacturing sites
- Working with business units and pricing teams when required
- Ensuring alignment between regulatory, commercial, and operational teams
Effective coordination ensures timely implementation of regulatory requirements. Assistant Manager Regulatory Affairs Job at AstraZeneca
Labeling Compliance and Regulatory Implementation
The role also involves monitoring new regulatory requirements related to product labeling.
Responsibilities include:
- Reviewing updates to Indian pharmaceutical labeling regulations
- Performing impact assessments for new regulatory guidelines
- Implementing regulatory updates within required timelines
- Ensuring compliance with national and global regulatory standards
Maintaining compliance helps prevent regulatory issues and ensures product approval.
QR Code and Serialization Support
The Assistant Manager will support initiatives related to packaging and product traceability.
Responsibilities include:
- Supporting QR code implementation and serialization processes
- Ensuring labeling compliance with regulatory and business requirements
- Coordinating with supply chain and packaging teams for implementation
Support for Partner and Regional Markets
The role may also involve supporting labeling requirements for external partners and nearby markets. Assistant Manager Regulatory Affairs Job at AstraZeneca
Responsibilities include:
- Supporting artwork developed for local distribution partners
- Providing labeling support for neighboring markets such as Nepal
- Ensuring regulatory alignment across regional markets
Audit Preparation and CAPA Implementation
The Regulatory Affairs team must ensure readiness for regulatory inspections and audits.
Responsibilities include:
- Preparing documentation for labeling audits
- Supporting internal and external regulatory inspections
- Implementing Corrective and Preventive Actions (CAPA) when required
- Maintaining compliance with internal and external regulatory standards
Product Launch Support
The role also contributes to regulatory activities related to product launches. Assistant Manager Regulatory Affairs Job at AstraZeneca
Responsibilities include:
- Coordinating with overseas manufacturing sites for first launch batch labeling
- Exploring strategies for early product launch implementation
- Supporting timely regulatory approval for new product packaging
Key Internal and External Stakeholders
Internal Stakeholders
The Assistant Manager will work closely with internal teams including:
- Marketing and sales teams
- Logistics and supply chain departments
- Medical affairs teams
- Legal and intellectual property teams
- Global product teams
- Quality assurance teams
- International regulatory affairs teams
External Stakeholders
External stakeholders may include:
- Local health authorities
- Government agencies
- Manufacturing partners
- Regulatory consultants
Eligibility Criteria
Educational Qualification
Candidates must possess one of the following qualifications:
- B.Pharm (Bachelor of Pharmacy)
- M.Sc in relevant life sciences discipline
Experience Required
Applicants should have:
- 3 – 6 years of experience in regulatory affairs
- Experience in pharmaceutical artwork development and labeling compliance
Technical Knowledge
Candidates should possess knowledge of:
- Indian pharmaceutical regulatory guidelines
- Drugs and Cosmetics Act (D&C Act) related to labeling requirements
- Artwork management systems
- Pharmaceutical packaging regulations
Skills Required
Candidates applying for this role should have the following skills:
- Strong understanding of regulatory labeling requirements
- Excellent communication and coordination skills
- Ability to manage multiple regulatory projects
- Strong documentation and record management abilities
- Analytical thinking and problem-solving skills
- Ability to work with cross-functional teams
Salary & Benefits
Salary for this position will be as per AstraZeneca company standards and will depend on candidate experience and qualifications.
Benefits of working at AstraZeneca may include:
- Opportunities to work with a global pharmaceutical leader
- Exposure to international regulatory operations
- Professional development and learning programs
- Collaborative work environment
- Long-term career growth in regulatory affairs
Selection Process
The recruitment process typically includes:
- Online application submission
- Resume screening by the HR team
- Technical interview related to regulatory affairs and labeling regulations
- Final HR or leadership interview
Candidates may be evaluated on their knowledge of regulatory guidelines, artwork development processes, and compliance requirements. Assistant Manager Regulatory Affairs Job at AstraZeneca
How to Apply
Interested candidates can apply for the Assistant Manager – Regulatory Affairs role through AstraZeneca’s official career portal. Assistant Manager Regulatory Affairs Job at AstraZeneca
Applicants should ensure their resume highlights:
- Regulatory affairs experience
- Artwork management expertise
- Knowledge of Indian regulatory requirements
- Experience working with cross-functional teams
Important Dates
| Event | Date |
|---|---|
| Application Deadline | March 31, 2026 |
Why Apply for This Regulatory Affairs Job?
Working at AstraZeneca provides professionals with an opportunity to contribute to regulatory compliance and product development within a global pharmaceutical company.
Key benefits include:
- Exposure to international pharmaceutical regulatory operations
- Experience managing product labeling and artwork development
- Opportunity to collaborate with global regulatory and commercial teams
- Career advancement in regulatory affairs leadership roles
- Contribution to the launch and lifecycle management of innovative medicines
This role is ideal for professionals seeking career growth in pharmaceutical regulatory affairs and product compliance management. Assistant Manager Regulatory Affairs Job at AstraZeneca
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical job opportunities for informational purposes only. We are not affiliated with AstraZeneca or any recruitment agencies.
Candidates should apply only through official company channels. Applicants are advised not to pay any recruitment or placement fees. Assistant Manager Regulatory Affairs Job at AstraZeneca
Final Call-to-Action
If you have experience in pharmaceutical regulatory affairs and artwork management, this opportunity at AstraZeneca could be an excellent step forward in your career. Qualified candidates are encouraged to submit their applications before the deadline and explore the chance to work with a global pharmaceutical leader. Assistant Manager Regulatory Affairs Job at AstraZeneca
