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Regulatory Affairs Director Emerging Markets AstraZeneca

Location: Cambridge, England, United Kingdom
Job reference: R-015237
Posted date: Nov. 14, 2017

Salary: Competitive

Location: Cambridge, UK

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 Emerging Market regulatory strategy for key development and marketed compounds? 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 2014, AstraZeneca delivered sales of nearly $6bn in emerging markets and was the third fastest- growing top 10 multinational pharmaceutical company. Your regulatory expertise will be key to opening up further opportunities for patients to access our rapidly expanding portfolio of ground breaking small and large molecules.

Main duties and responsibilities

You’ll have responsibility for developing and implementing an innovative and robust emerging markets regulatory strategy for AstraZeneca products to drive optimal market access for patients whilst ensuring all labelling is in keeping with product properties and patient needs.

Working with commercial and cross-functional teams to ensure that emerging market opportunities are understood and aligned with global regulatory strategies, you’ll be expected to deliver ambitious regulatory milestones. Partnering with affiliates to take creative and innovative strategies to regulatory authorities in emerging markets, being a key contributor to project teams, engaging policy shapers and influencers and providing regulatory intelligence will all be on your agenda. In addition, you will contribute the emerging markets perspective to process improvement activities with the aim of simplification, 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
  • 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

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law