Manager Scientific Regulatory Strategy

Philip Morris International

  • Neuchâtel
  • CDI
  • Temps-plein
  • Il y a 2 mois
Manager Scientific Regulatory Strategy - Neuchatel, SwitzerlandBe a part of a revolutionary change.At PMI, we've chosen to do something incredible. We're totally transforming our business, and building our future on smoke-free products.With huge change, comes huge opportunity. So, wherever you join us, you'll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.It's so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that's exactly what's happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products.Join us and you'll have the resources, support and technology you need to break new ground and see ideas come to life. You'll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers.If you're creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future.Your 'day to day'As a Manager Scientific Regulatory Strategy you will be responsible for development, support and execution of regulatory strategy for the different Life Science platforms and categories, global regulatory classification options for new products, and appropriate regulatory pathways, regulatory strategies to support approval.You will support and contribute to delivery of product regulatory strategy worldwide, including pre-market, submissions worldwide and all unique and recurrent post-market obligations worldwide. You will be accountable for Regulatory Affairs support and deliverables linked to new product developments as well as management of lifecycle activities and projects, including product submissions and registrations.You will lead regulatory submissions program planning & delivery to receive regulatory approval in all markets, as well as contribute to the regulatory compliance, submissions and definition of standards for PMI Products.More specifically, you'll
  • Collaborate with External Affairs colleagues locally and centrally to ensure clear regulatory product strategies are developed, documented and maintained that ensure the appropriate technical documentation is developed and delivered to local markets to allow timely product launches to occur.
  • Guide the R&D development process through a sound communication on regulatory expectations to key Life Science and Product teams.
  • Drive the content development of technical documentation required to support market authorisations and product maintenance. Ensure any product dossiers are clearly and coherently written and meet Authority requirements for submission purposes.
  • Ensure timely, ongoing regulatory support and documentation is provided to local markets in response to regulatory authority questions on our smokefree products.
  • Keep abreast of global regulations, anticipate change and drive proactive planning of initiatives to develop measures for complex regulatory challenges. Counsel and advise management on global regulatory strategies and practices.
  • Use global regulatory experience and precedents to help shape the company's internal thinking and approach to new product regulation that continues to see PMI evolve and adapt in its regulatory service model.
Who we're looking for
  • MSc in relevant scientific area. Postgraduate qualification a bonus.
  • Substantial regulatory experience in related industries.
  • Good knowledge of global regulations relevant to regulated products preferably in chemicals or consumer goods.
  • Broad experience in communicating, leading interactions and working with major regulatory agencies.
  • Sound experience in providing strategic regulatory advice for development of products in regulated industries.
  • Strategic, analytical and innovative thinking capability to drive solutions to complex regulatory issues.
  • Very good interpersonal, communication and networking skills to create impact and influence and to build strong alliances internally and externally. Able to present detailed complex issues in a simple, precise manner.
  • Ability to handle ambiguity, short deadlines, fast changing environments.
  • Demonstrated capabilities of working in a matrix organization.
  • Fluent in English, both written and spoken.
What we offer
Our success depends on the people who come to work every single day with a sense of purpose and an appetite for progress.Join PMI and you too can:
  • Seize the freedom to define your future and ours. We'll empower you to take risks, experiment and explore.
  • Be part of an inclusive, diverse culture, where everyone's contribution is respected; collaborate with some of the world's best people and feel like you belong.
  • Pursue your ambitions and develop your skills with a global business - our staggering size and scale provides endless opportunities to progress.
  • Take pride in delivering our promise to society: a smoke-free future.
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Philip Morris International