Associate Regulatory Affairs Director I
Job Title: Associate Regulatory Affairs Director I
Global Career Level: E
Introduction to role
Are you ready to be part of a team that turns drug development strategies into reality? As an Associate Regulatory Affairs Director I, you will lead the planning, coordination, and execution of regulatory deliverables. This role requires a dynamic individual who can navigate various responsibilities, from regulatory project management to dossier management, ensuring our innovative medicines reach patients efficiently. Are you prepared to challenge the status quo and drive the right approvals for AstraZeneca's expanding pipeline?
Accountabilities
In this role, you will be a key contributor to regulatory submission strategy, identifying risks and opportunities while leading applications through approval. You will provide expertise and guidance on procedural and documentation requirements, collaborating with cross-functional teams to achieve business objectives. Your responsibilities will include managing regulatory publishing deliverables, maintaining submission plans, and ensuring compliance with health authorities. You will also mentor junior staff, contribute to process improvement, and potentially lead teams or market-specific projects.
Essential Skills/Experience
Relevant University Degree in Science or related discipline
Minimum 10 years regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing and of working across a range of markets, including 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
Managed complex regulatory deliverables across projects/products
Experience of working with people from locations outside of India, especially Europe and/or USA
Desirable Skills/Experience
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 stakeholder management skills
Ability to analyze problems and recommend actions
Continuous Improvement and knowledge sharing focused
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, innovation is at our heart. We are committed to turning life-changing science into medicines that make a difference for patients worldwide. Our collaborative environment empowers you to ask questions, try new things, and lead breakthroughs. With a focus on technology adoption and automation, we strive for efficiencies that drive new innovations. Join us in our mission to bring life-changing medicines to patients and be part of a diverse team that values your unique contributions.
Ready to make an impact? Apply now and be part of our journey to push beyond traditional boundaries in Regulatory Affairs!
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 authorisation and employment eligibility verification requirements.
