Job Title: Regulatory Affairs Manager I

Career Level - D

Introduction to Role:

Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected to work flexibly to deliver varied accountabilities as assigned to you by your line manager or by the Lead Regulatory Project Manager (RPM) for your allocated Global Regulatory Execution Team (GRET).

Accountabilities:

As a Regulatory Affairs Manager I, you will contribute to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. You will provide 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. You will also be 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.

Essential Skills/Experience:

• Relevant University Degree in Science or related discipline

• Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry

• Thorough knowledge of the regulatory product maintenance process

• Strong project management skills

• Leadership skills, including experience leading multi-disciplinary project teams

• Regulatory affairs experience across a broad range of markets

• Managed regulatory deliverables at the project level

• 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, 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 are proactively involved in the strategy, changing the course for approvals and influencing regulators on new technology. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. We are striving for technology adoption and automation to drive efficiencies and new innovations.

Are you ready to innovate in a safe environment? Join a team with deep specialist knowledge and Regulatory expertise. We are confident in what we know and what it takes to ideate and innovate towards better solutions. Apply now!

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.