Job Description

Job Title: Regulatory Affairs Manager I

Career Level - D

Introduction to role:

The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The Regulatory Affairs Manager I is fully proficient in applying established standards to perform regulatory affairs management for simple/moderately complex products/regions and under minimal supervision. Capable of leading cross functional activities. Participates continuous improvement of process and tools/systems.

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. Provides regulatory labeling expertise and leads the maintenance of labeling documents for allocated products. Is responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labeling for allocated products 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, including license maintenance, labelling and publishing, and of working in regulated markets

- General knowledge of drug development

- Good knowledge of the regulatory product maintenance process

- Strong project management skills

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

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

- Basic understanding of emerging technologies like AI, ML etc

- Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration and learning

- Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making.

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\xe2\x80\x99s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\xe2\x80\x99re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We\'re always looking for someone different to join our efficient and nimble team. If you can offer us some original thinking, a different approach or skillset, then you\'ll fit in. Confident in stepping up and taking accountability, we showcase what Regulatory can do around the business. Above all, it\'s our curiosity that keeps us going. Committed to digging deep into complex areas and finding a better way to realise our pipeline and reach our patients.

Ready to make a difference? Apply now!

Date Posted 12-Mar-2024

Closing Date 31-Mar-2024

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.

AstraZeneca