Regulatory Affairs Director (Emerging Markets)

At AstraZeneca, we make a difference every day by delivering life–changing medicines to millions of people globally. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. This means we are opening up new ways to work, ground–breaking methods and bringing excellent teams together. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an exceptional place to work!

We have an opportunity for a *Regulatory Affairs Director (RAD) – Emerging Markets *to join our team. Emerging Markets Regulatory Affairs (EMRA) drive innovative, international, regulatory and patient–centric strategies enabling simultaneous global access to our products. We have a three–pillar strategy in Emerging Markets: Expansion, Innovation and Partnership.

You will provide strategic leadership and have an understanding of regulatory science across international regions. Your experience and knowledge of drug/biologic development processes and strategies will enable you to influence cross–functional discussions with product teams. A thorough understanding of international commercial factors is needed for success in this role.

*Key accountabilities / responsibilities: *

*Project Regulatory Strategy*

* Development and implementation of innovative regulatory strategies designed to deliver a rapid approval. Strategy should reflect international requirements.
* Develop, communicate and update the International section of the Regulatory Strategy Document for assigned products/projects.
* Delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures.
* Lead the objective assessment of emerging data against aspirations and update leadership teams on project risks and mitigation activities.

*Leadership*

* Single point of contact and Regional Regulatory Affairs representative on Regional Product Teams (across the Emerging Markets)
* Planning and creation of the International dossier
* Build and implement an optimal regulatory strategy for product(s) ensuring International needs are incorporated into the Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
* Ensure business needs are understood within the Global Regulatory Strategy Team; encourage regional commercial engagement with proposed regulatory strategies, risks and mitigation plans.
* Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
* Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered to time and quality.
* Provide leadership in product in–license/due diligence review, product divestment and product withdrawal.
* Proactively contribute across RAD community and Regulatory Excellence objectives and activities.

*Regulatory Environment*

* Partner with commercial teams to monitor changes in the regulatory environment; support and advise accordingly.
* Collaborate with commercial colleagues to influence guidance within leading Health Authorities.

*Essential Criteria:*

* Bachelor's degree in a science related field
* Previous experience with Major Health Authority interactions
* Extensive knowledge of regulatory drug development including product approval/launch.
* Broad background in pharmaceutical business and experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
* Leadership and program management experience.
* Ability to think strategically and critically evaluate risks to regulatory activities within a complex, critical, high–profile development program.
* Successful contribution to a major regulatory approval in the International Region
* Commercial and cross–cultural awareness; can work independently with Commercial and Marketing Company colleagues from across the globe.
* Must demonstrate competencies of: critical thinking, strategic influencing, innovation, initiative, leadership and proficiency with both written and verbal communications.

*Location: Cambridge UK, other locations can be considered*