Regulatory Affairs Manager I

Job Title: Regulatory Affairs Manager I

Career Level - D

Introduction to role:
Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You will be responsible for various roles within a Global Regulatory Execution Team (GRET), including Regulatory Affairs Management, Global Labelling Management, and Dossier Management. 

Accountabilities:
As a Regulatory Affairs Manager I, you will contribute to regulatory submission strategy, identifying submission risks and opportunities. You will lead simple through more complex regulatory applications and manage procedures through approval. You will also provide regulatory labeling expertise and lead the maintenance of global labeling documents for allocated products. Additionally, you will plan and manage Regulatory and basic Clinical and Non-Clinical publishing deliverables.

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 

Desirable Skills

- 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 are constantly evolving, taking creative thinking and change seriously. We support each other to ask questions, try new things, and identify what's next to promote our products in a better way. 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. 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 team that values your influential work in shaping drug development? Are you curious by nature, ready to dig into challenges to get to the core of a solution? If so, apply today!