Global Regulatory Affairs Director Early R&I

At AstraZeneca, we lead our industry in the development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science and medicine.

The Global Regulatory Affairs Therapeutic area team is a strategic function and plays a key role within the Global Product Teams who work cross functionally to gather expertise and knowledge that informs our drug development programs. We are ultimately responsible for ensuring that the pieces fit together to deliver for patients and physicians and provide therapy area regulatory expertise that supports regulatory interactions across the globe to secure fast submissions for our medicines in development.

We are now offering an exciting opportunity for a Global Regulatory Affairs Director to join our group within Respiratory and Inflammation (R&I). This role is preferable based at AstraZeneca's dynamic R&D sites in Gothenburg (Sweden), Cambridge (UK), Gaithersburg and Durham (US).



What you'll do

The Global Regulatory Affairs Director is accountable for leading the development and implementation of the global regulatory strategy for a group of products of increasing complexity within the R&I portfolio. You will ensure that the strategy is designed to deliver rapid approval with advantageous labelling in keeping with the properties of the products and the needs identified by the business, markets and patients. For this role the focus will be on Early Development, innovation and novel transformative endpoints.

This role requires a well experienced Regulatory Affairs Director with strategic leadership skills, a deep understanding of global regulatory science and overall drug/biologic development processes. Experience and knowledge within the Respiratory or Inflammation disease areas is an advantage in order to be able to influence cross-functional discussions with Global Product Teams (GPT) and relevant stakeholders. Also previous experience of working with strategies for high profile, complex or novel development programs is preferred. This role includes the ability to take on the Global Regulatory Lead (GRL) for one or more products and to function in dual capacity by delivering the overarching global regulatory strategy as well as serve as a regional lead.



Your main accountabilities / responsibilities:

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Work on cross-project initiatives of high importance for the early R&I portfolio
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Lead the development and implementation of innovative global strategies
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Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk analysis and mitigation measures
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Lead the planning and construction of the global dossier and core prescribing information
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Serve as the single point of contact and GRL/Regional Lead on Global Project Teams (GPT)
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Lead the Global Regulatory Sub-team (GRST) or as a Regional Lead with key contributing members from regional perspectives, emerging markets, Reg CMC as well as delivery & enablement
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Partner with marketing company and regional regulatory affairs staff
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Lead key cross-department or cross-functional projects on behalf of Global Regulatory Affairs (GRA) when necessary
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Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal
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Participate in skill-development, coaching, and performance feedback of other regulatory staff
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Provide a regional focus and interact with commercial to understand business needs and to ensure regional commercial engagement with the proposed regulatory strategies



Essential for the Role:

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Advanced degree in a science related field and/or other appropriate knowledge/experience
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Previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.)
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Over 5 years' experience or equivalent of regulatory drug development including product approval/launch
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Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority
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Ability to think strategically and critically evaluate risks to regulatory activities
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A scientific and clinical understanding of the regulatory sciences
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Must demonstrate competencies of strategic thinking and influencing, innovation, initiative, leadership and excellent oral and written communication skills



Desirable Requirements:

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Expert knowledge of regulatory affairs within one or more relevant therapeutic areas. In this case, any previous experience in respiratory and immunology diseases is also useful
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Experience in relevant therapy area (small molecules & biologics)



So, what's next?

Are you already imagining joining our team of Global Clinical Heads? Good, because we can't wait to hear from you! Welcome with your application no later than December 12, 2021.