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International CMC Regulatory Affairs Manager I

AstraZeneca -
Bengaluru, Karnataka

Apply Now

Job details

Full-time
9 days ago

Qualifications

PMP
Research
Project management
Bachelor's degree
Manufacturing

Full job description

Posted date Aug. 25, 2026

Contract type Full time

Job ID R-258782

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

Job ID R-258782 Date posted 08/25/2026

Job Title: International CMC Regulatory Affairs Manager I

Global Career Level: D

Role Type: Individual Contributor for International Markets

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work.

About the role

Introduction to role

The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. They project manage international CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.

They will ensure the application of international CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance, policy, and processes.

Accountabilities

Manage the timely preparation (include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout marketing authorisation applications and all post approval activities

Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.

Documenting maintenance and communication of Health Authority approval status.

Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.

Project management expertise with the ability to adapt to changing situations to ensure on time delivery.

Ensure the learning from own projects are shared with other colleagues/within the functions.

Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission content

Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.

Contribute to business process optimisation activities to reduce waste and ensure efficiency.

Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions, responses and commitments.

Apply GxP principles according to the stage of product lifecycle

Responsibility for change management as assigned.

Understands application of appropriate risk management across own activities.

Demonstrate research skills in understanding regulations, and guidance from different regulatory agencies

Essential Skills/Experience

University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
Minimum 8 years of Relevant experience from biopharmaceutical industry, or other relevant experience
Breadth of knowledge of manufacturing, project, technical and regulatory management.
IT Skills
Stakeholder & Project management
Professional capabilities: Regulatory knowledge

Desirable Skills/Experience

Knowledge of the drug development process and regulatory submissions
Understanding of current regulatory CMC requirements
Direct/indirect Regulatory Affairs CMC experience with submissions for medicinal products
Understanding of regulations and guidance governing the manufacture of medicinal products
Lean capabilities

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

AstraZeneca offers the chance to work on meaningful science that directly shapes how life-changing medicines reach patients worldwide, with a rich pipeline that spans the full drug development journey. Regulatory professionals collaborate across locations, therapy areas and external partners to solve complex problems, use data and analytics to shorten development cycles, and pioneer modern regulatory approaches for niche patient populations. It is an inclusive environment where diverse perspectives are valued, people are trusted with real responsibility, encouraged to ask questions, try new ideas and act as agents of change, while benefiting from global opportunities to grow skills, explore different roles and build a long-term career.

Where Can I Find Out More?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Call to Action:

Ready to step up, drive impactful CMC submissions and help bring transformative medicines to patients faster? .

AstraZeneca 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 align with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

25-Aug-2026

Closing Date

10-Sept-2026

AstraZeneca 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.

Explore the local area

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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.

Sales Representative Oslo, Norway

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.

Sales Representative California, United States

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.

Sales Representative Petaling Jaya, Malaysia

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.

Apply Now

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