Job Description

Job Title: Associate Regulatory Affairs Director I

Career Level: E

Introduction to role:

The Associate Regulatory Affairs Director I is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables as an individual contributor and is fully proficient in applying established standards. Performs and leads regulatory affairs management independently for moderately to highly complex products/regions. May provide strategic input, capable of leading cross functional and cross project activities. Mentors junior level staff as buddy within given role. Leads continuous improvement of process and tools/systems. Proficient in risk and issue identification and mitigation (within GRET or xTA GRETS). Drives initiatives for efficiency/productivity for the GRET and across xTA GRETs.

Accountabilities:

The Associate Regulatory Affairs Director I Is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading 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.

Essential Skills/Experience:

- Relevant University Degree in Science or related discipline

- Minimum 10 years of relevant regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing and of working across a range of markets, including regulated markets

- Good 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

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 (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

- 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.

At AstraZeneca, we are independent thinkers who step up to represent Regulatory in the wider enterprise. Embrace the opportunity to lead across levels, departments and drug modalities. With absolute accountability for Regulatory strategy and its execution, we are a valued part of the business. 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.

Are you ready to make a difference? Apply today and join us in our mission to improve the health of millions worldwide!

Date Posted 28-Nov-2023

Closing Date 08-Dec-2023

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