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 Policy and Regional Strategy Support Director to join our team.

Do you have significant experience of regulatory drug development and proven successful leadership and project management experience?  Are you keen to join a world-leading pharmaceutical company and lead the Policy and Regional Strategy supporting China?  This key role will assess the impact of new legislation in China for our key development and marketed compounds.  It will also include leadership at external and internal fora to influencing guidelines impacting drug development and patient access.  At AstraZeneca we’re looking for a Regulatory Affairs Director to be based at our global headquarters in Cambridge, UK.

Emerging markets comprise countries with dynamic, growing economies, representing a major growth opportunity for AstraZeneca and as a result one of the company’s growth platforms.  In 2020, AstraZeneca was the third fastest- growing top 10 multinational pharmaceutical company in Emerging markets.  Your regulatory expertise will be key to opening up further opportunities for patients to access our rapidly expanding portfolio of groundbreaking small and large molecules.

Main duties and responsibilities

• The Policy and Regional Strategy Support Director drives Regulatory policy for China and strategic initiatives supporting the Marketing Company (MC) Regulatory teams.  This role provides regulatory procedural/environmental advice on assigned policy or project topics and attends relevant external meetings or conferences of value to the business. 

• Assess impact of new legislative/environmental changes on product strategy and communicate relevant information to GPTs

• Represent AZ Regulatory Affairs on selected external Trade Association committees to ensure AZ Regulatory views on key issues are known

• Cross-functional leadership of process improvements and ways of working

• Contributes to the strategy, direction and efficient operation of the Policy, Intelligence and Regional Strategy (PIRS) group including continuous improvement initiatives. 

Working with commercial and cross-functional teams to ensure that opportunities and risks in the China environment with rapid legislation reform are understood and aligned with global regulatory strategies.  Partnering with affiliates to take creative and innovative strategies to regulatory authorities and engaging policy shapers and influencers and providing regulatory intelligence will all be on your agenda.  In addition, you will contribute to the emerging markets perspective to process improvement activities with the aim of simplifying, streamlining and refining our processes to continue to improve our ways of working.

Essential Requirements

• Bachelor’s Degree in Life Science or related discipline, advanced degree a plus.

• Significant experience of regulatory drug development, and regulatory approvals/product launches within emerging markets or experience at a health authority

• In depth understanding on the China environment and specific filing experience

• Proven leadership and programme management experience

• Strong influencing and negotiation skills

• Successful cross-functional and stakeholder management

• In-depth knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance in emerging markets

• Excellent communication skills and cross-cultural awareness

• Strong problem solver and decision making skills

Location: Cambridge UK, other locations can be considered

Date Posted

Closing Date

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.