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 Title: CMC Regulatory Affairs Associate Director II
Global Career Level: E
Introduction to role
Are you a strategically focused Regulatory CMC professional eager to play an integral part in bringing life-changing medicines to patients? If so, please read on!
As a CMC Regulatory Affairs Associate Director II, you will provide essential CMC Regulatory Strategy, operational, tactical, and decision-making expertise for projects and complex product ranges from early clinical development through to launch and post-approval lifecycle management for global markets. You will represent CMC Regulatory Affairs across various business networks, including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, and Global Quality and Operations. You may also lead the development of new guidance, policy, and processes, facilitating high-quality partnerships within and external to AstraZeneca. Your role will support CMCRA for products/projects and/or specialist areas, with a deep understanding of the complexities and challenges required for Dossier submissions and proven project management skills.
Accountabilities
- Provide CMC RA expertise across business functions and potentially lead key business improvement initiatives.
- Offer strategic CMC RA expertise and direction for CMC submissions across the product lifecycle, supporting novel strategies and new approaches from technical functions.
- Lead CMC-related interactions with Health Authorities when necessary.
- Provide regulatory strategic guidance in support of operational initiatives, such as complex/accelerated projects and post-approval changes.
- Contribute to or lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca.
- Share knowledge by leading/contributing to Communities of Practice across groups or within a business unit.
- Manage high-level risk by making complex judgments and developing innovative solutions, including proactive risk management and mitigation.
- Provide clear, concise guidance on current CMC regulatory requirements to support business tactical and strategic planning.
- Support the development and implementation of novel strategies in CMC regulatory affairs to enhance efficiency and flexibility in the CMC dossier.
- Contribute to cross-therapeutic non-drug projects and support business processes to ensure accelerated submissions, launch activities, regulatory information management, and regulatory compliance on behalf of AstraZeneca.
Essential Skills/Experience
- Bachelor's degree in Science, Regulatory Sciences, or Pharmacy.
- Breadth of knowledge of manufacturing, project, technical, and regulatory project management.
- Strong understanding of regulatory affairs globally.
- Direct Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products.
- Stakeholder & Project management.
Desirable Skills/Experience
- Master's degree or PhD in Science, Regulatory Sciences, or Pharmacy.
- Business, financial, and supply chain understanding/awareness.
- Experience with regulatory health authority interactions, inspections, and/or external advocacy/regulatory policy.
- Experience in line and/or matrix leadership.
- Experience with clinical development of innovative pharmaceutical APIs and Drug Products.
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.
At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines that achieve the best results for patients in need and healthcare professionals. Our innovative mindset drives us to think broadly about patients' needs and what it takes to prevent and treat diseases. We are valued for our influential work in shaping drug development and gaining fast, efficient approvals. Our dynamic team is empowered to make quick decisions while operating independently yet collaboratively. We are always looking for original thinkers who can offer different approaches or skillsets. Our curiosity drives us to dig deep into complex areas to realize our pipeline and reach our patients.
Ready to make a difference? Apply now to join our team!
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.
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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