Job Title: Associate Regulatory Affairs Director I
Career Level - E
Introduction to Role:
Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This role offers the opportunity to work across varied stages and molecules, providing a dynamic and challenging environment that will expand your skills and knowledge.
As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval. You will also provide regulatory expertise on procedural and documentation requirements to various teams, ensuring the delivery of business objectives. You may also be responsible for the maintenance of global labeling documents for allocated products and the planning and management of Regulatory and basic Clinical and Non-Clinical publishing deliverables.
Relevant University Degree in Science or related discipline
Minimum 9 years of relevant regulatory experience within the biopharmaceutical industry
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
Experience managing complex regulatory deliverables across projects/products
Experience working with people from locations outside of India, especially Europe and/or USA
Excellent English written and verbal communication skills
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
Proficiency with common project management (eg 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, we are committed to turning our drug development strategies into reality. We think broadly about patients and what it takes to prevent and treat diseases. We value innovation, creative thinking, and change. We are a diverse and open-minded team that thrives on exploring new ideas and ways of doing things. We are part of the solution, involved in key discussions, acting as both a drug developer and Regulator. We constructively challenge each other to think of the best approach and influence external Regulators. We are striving for technology adoption and automation to drive efficiencies and new innovations.
Are you ready to be part of a dynamic team that's empowered to make quick decisions? Are you curious by nature, ready to dig into challenges to get to the core of a solution? If so, apply today!
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.