Job Description

We have an opportunity for an Associate Regulatory Affairs Director to join our team!

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you\xe2\x80\x99re our kind of person.

What you\xe2\x80\x99ll do

The Associate Regulatory Affairs Director (ARAD) in International Regulatory Affairs is a highly experienced regulatory specialist who will focus on providing expert Regulatory advice and project management together with strong leadership within the Regulatory Affairs Management (RAM) team in International Regulatory Affairs. They will work collaboratively with International RADs (iRADs) to ensure optimised and accelerated tactical delivery of International market submissions in line with International Commercial priorities. They will effectively partner and collaborate with RAM colleagues in the TA\xe2\x80\x99s to ensure seamless delivery according to AZ business objectives. They will have an exceptional proven track record working with International markets, a strong cultural awareness, excellent collaborative skills, advanced problem-solving abilities along with a Continuous Improvement mindset and a natural ability to effectively coach and mentor. Reporting to the Director Group Manager in the International RAM (iRAM) team, this role is unique opportunity to work in a rapidly changing and diverse Regulatory environment with other highly specialised and skilled individuals in an area of high importance to the AZ business.

Responsibilities:

Provide Int\xe2\x80\x99l market Regulatory expertise to enable efficient and streamlined tactical delivery of International market submissions including:

Optimisation of submission delivery strategies for assigned products/markets including advising on tactical decision-making

Effective communication and collaboration to remove obstacles from submission preparation process and support Marketing Companies in rapid filings and responses to HAQs

Use and sharing of best practice working with Int\xe2\x80\x99l markets within the RAM community and role-modelling effective delivery of complex Int\xe2\x80\x99l market submissions

Partner with the RAM Market Contacts to feedback applied and relevant knowledge and experience gained from Int\xe2\x80\x99l market submissions to facilitate knowledge-sharing

Provide support across iRAM to maintain and continuously improve regulatory consistency and to achieve \xe2\x80\x9cright-first-time\xe2\x80\x9d submissions in line with agreed plans and metrics

Ensure development and maintenance of key collaborative relationships and ensure alignment of objectives and visibility of issues/risks and driving issue resolution where necessary

Subject matter expert input into Regulatory Intelligence initiatives eg Regulatory Requirements Repository (R3) project

Education, Qualifications, Skills and Experience

Essential for the role:

Degree in Science or related field

Extensive regulatory experience within the biopharmaceutical industry with 10+ years working with International markets

Thorough understanding of drug development and Int\xe2\x80\x99l market Regulatory frameworks

Proven track record of management of complex regulatory deliverables for International market MAA\xe2\x80\x99s and CLEs across projects/products

Strong project and stakeholder management skills

Highly developed interpersonal skills, including experience leading multi-disciplinary project teams

Global working and expert knowledge of International Markets

Extensive experience of managing first-wave Marketing Application and/or LCM submissions

Proven track record of managing complex regulatory deliverables across projects/products

Why AstraZeneca?

At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We\xe2\x80\x99re on an exciting journey to pioneer the future of healthcare.

So, what\xe2\x80\x99s next?

Are you already imagining yourself joining our team? Good, because we can\xe2\x80\x99t wait to hear from you!

Competitive salary and benefits package on offer.

Where can I find out more?

Our Social Media,

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Date Posted 19-Jan-2023

Closing Date 18-Feb-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