We have an opportunity for an Associate Regulatory Project Director to join our team! This role can be based in either location to include Cheshire, UK / Cambridge, UK/ Gothenburg, Sweden/ Bangalore, India/ Gaithersburg, US

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies!

What you’ll 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’s 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.

Provide Int’l 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’l markets within the RAM community and role-modelling effective delivery of complex Int’l market submissions

  • Partner with the RAM Market Contacts to feedback applied and relevant knowledge and experience gained from Int’l market submissions to facilitate knowledge-sharing

  • Provide support across iRAM to maintain and continuously improve regulatory consistency and to achieve “right-first-time” 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

Essential Requirements:

  • Degree in Science or related field

  • Extensive regulatory experience within the biopharmaceutical industry with experience working with International markets

  • Thorough understanding of drug development and Int’l market Regulatory frameworks

  • Proven track record of management of complex regulatory deliverables for International market MAA’s 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

Competitive salary package and benefits

Close Date: 01/04/2022

Why AstraZeneca?

We feel a strong sense of pride and accomplishment playing our part in making a positive difference to medical science, patients and society – promoting health and wellbeing all around the world.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

If you’re curious to know more then please reach out to Louise Bennett

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