Job Description

Job Title: Regulatory Affairs Manager I

Career Level: D

Introduction to Role:

Are you a regulatory specialist with project management capabilities? Do you thrive in a dynamic environment and enjoy leading the end-to-end planning, coordination, and execution of assigned deliverables? If so, we have an exciting opportunity for you! As a Regulatory Affairs Manager I at AstraZeneca, you will be responsible for regulatory affairs management, global labelling management and dossier management. You will be expected to work flexibly to deliver these varied accountabilities as assigned to you by your line manager or by the Lead Regulatory Project Manager (RPM) for your allocated GRET(s).

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.

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

- 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

- Experience of working with people from locations outside of India, especially Europe and/or USA

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

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?

At AstraZeneca\'s Oncology R&D department, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We are all compassionate team players and driven achievers, always ready to step up. We\'re motivated by science, success and achieving our goals in a way that\'s novel and thoughtful. We see change as an opportunity, embracing the possibility to learn, grow and evolve.

Are you ready to step up, take ownership of your work, solutions for the business and your personal career development? Apply now and join us in our mission to bring life-changing medicines to people.

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Date Posted 18-Jan-2024

Closing Date 31-Jan-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