Why choose AstraZeneca India?
Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare.
The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports.
Who do we look for?
Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.
Success Profile
Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.
Tech innovators
Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives.
Ownership takers
If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it.
Challenge seekers
Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks.
Proactive collaborators
Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best.
Responsibilities
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Job Description/ Capsule
- Collates information, communicates, and prepares responses for Health Authority queries to facilitate regulatory processes.
- Maintains and updates submission trackers to ensure accurate and up-to-date regulatory documentation.
- Supports the development of India-specific artwork, ensuring compliance with regulatory requirements.
- Supports the preparation and submission of regulatory dossiers for new drug applications, additional indication, GCT applications, site registrations and import licenses as and when assigned.
- Coordinates lifecycle management activities for assigned products, addressing renewals and updates as needed.
- Prepares and submits Periodic Safety Update Reports (PSURs) as and when assigned.
- Support team for testing of samples by preparing and submitting required documents and letters to NIBL or CDTL.
- To support any additional upcoming RA project as and when delegated.
Core Accountabilities
Key Result Areas/ outputs:
• Adherence to AZ and industry codes of conduct, ethics and good regulatory practices • Ensure that all licensing activities for assigned products are completed in full compliance with all applicable regulations and relevant standards.
• Assist in Issue Management
• Regulatory Intelligence
• Management of India PSUR submission
• Handles submission/review/query responses for commercial products/global clinical trials including SEC preparation
• Maintain complete documentation records and all trackers maintained
• Manage changes in product Licenses and coordinate with changes, planned and in progress
• Support relevant Audits internal and external
• Support Deviations and CAPA as required
• Learn or gain detailed knowledge of critical aspects of products: commercial strategies, the content of dossiers, regulatory intelligence, regulatory timelines and supply strategy and proactive preparation of required steps, manage local testing and legal documents for new launches.
Adherence to AZ and industry codes of conduct, ethics and good regulatory practices
• Align with the values and vision of AZ
• Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate
• Governance and Audit requirement
• Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information)
• Disclose potential breach of codes or conducts. Ensure that all licensing activities are completed in full compliance with all applicable regulations and relevant standards.
• Support in application compilation and the respective query management and communicating the progress till approval/closure within RA team.
Assist in Issue Management
• Provide detailed information of regulatory status of affected products
• Undertake assigned follow-up action where necessary
Regulatory Intelligence
- To stay updated on new regulatory guidelines, circulars, public notices, and alerts issued through Health
- Authority websites and to circulate this information within the team for timely action.
Management of India PSUR submission
• Prepare India specific PSURs based on the global PBRER
• Submit the PSURs to Health Authorities within timeline
• Responsible for responding to Health Authority Questions based on PSUR
Handling submission/review/query responses for commercial products including SEC preparation
• Manages regulatory compliance including renewal/amendments minimum supervision from manager
• Maintain complete documentation records and all trackers are timely maintained
Support relevant Audits internal and external, Deviations & CAPA action
• Support internal and external audits by ensuring all regulatory documents and processes are audit-ready and addressing audit requirements in a timely manner.
• Assist in managing deviations and implementing CAPA actions, ensuring compliance with regulatory standards and continuous process improvement.
Location : Mumbai
Education, Qualifications, Skills and Experience.
Essential:
- Degree or equivalent professional qualification in related field
• Experience in quality assurance within a pharmaceutical manufacturing environment.
Desirable: Post-graduate qualification
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
If you have site, country or departmental social media then feel free to switch any of the above links.
Date Posted
10-Dec-2025Closing Date
18-Dec-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Reasons to Join
Thomas Mathisen
There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.
Christine Recchio
Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.
Stephanie Ling
There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.
What we offer
We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.
Lifelong learning
Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still.
Autonomy and reward
Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package.
Health and wellbeing
An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority.
Inclusion and diversity
Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.
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