Accountabilities
Regulatory Affairs Management
- Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.
- Provides regulatory expertise and guidance on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST), and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Global Labelling Management
- Provides regulatory labeling expertise and leads the maintenance of global labeling documents for allocated products.
- Responsible for the regulatory activities involved in the coordination, development, and implementation of revised printed labeling for allocated products, including USPIs and other regional labeling.
Dossier Management
- Plans and handles Regulatory and basic Clinical and Non-Clinical publishing deliverables, as well as associated lifecycle and license information.
- Collaborates with publishing teams to assure efficient delivery of end-to-end submission output to project timelines.
Essential Skills/Experience
- Relevant University Degre in Science or related subject area
- Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling, and publishing, and of working in regulated markets
- General knowledge of drug development
- Thorough knowledge of the regulatory product maintenance process
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Excellent English written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (e.g., MS Project) and document management tools
- Ability to work independently and as part of a team
- Influencing and partner management skills
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused
Desirable Skills/Experience
- Regulatory affairs experience across a broad range of markets
- Managed regulatory results at the project level
- Experience of working with people from locations outside of India, especially Europe and/or USA
When we put unexpected teams in the same room, we ignite 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.
AstraZeneca offers an environment where you can be at the forefront of medical innovation. We use our unique position as medical leaders across our enterprise and the healthcare ecosystem to shape the future of healthcare. Here, you can make a significant impact on patients' lives while developing your career in a dynamic and fast-paced setting. Our collaboration sets us apart, driving innovation that makes a real difference.
Ready to make a difference? Apply now to join our growing BioPharmaceuticals team!
Date Posted
Closing Date
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.