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Director Regulatory Science

Are you up for a challenge? Do you look for ways to grow in your job? And do you want to build a phenomenal career? Then apply now! We are currently looking for a: Director Regulatory Science We don’t just want any Director, here is our checklist: Medical Doctor (MD) Senior medical leader with substantial relevant experience in the food, consumer goods or pharmaceutical industry (or similar experience) In depth knowledge of product assessment and regulatory science Senior leader with proven experience in formulating and implementing regulatory science strategies based on available evidence to help shape emerging regulatory frameworks through scientific discussions with regulators and to enable product introduction in a given market and increase business value Experienced leader and communicator to Senior Management, Key Opinion Leaders (KOLs), professional health organizations, consumers and media Proven track record of successfully building and leading effective cross-functional, cross-cultural, global teams, embracing change Demonstrated knowledge of relevant regulatory guidance and standards globally (e.g., FDA, ICH and EMEA). Fluent in both oral and written English. If you are also good with deadlines, teamwork and feedback from different stakeholders and management, while operating in a challenging and consistently changing environment, you are the one we want for our Scientific and Medical Affairs Team, in Philip Morris Products S.A., Science and Innovation, in Neuchâtel, Switzerland. As a Director Regulatory Science, you will be accountable for the development of the scientific content of regulatory submission documents in alignment with PMI’s scientific and regulatory submission strategy for all product platforms in alignment and close collaboration with Philip Morris Products S.A. External Affairs and Science and Innovation Engineering, Technology and Quality. You will ensure that the overall scientific and medical content reflects the current state of product evidence, and enables the mutually agreed regulatory strategy. You ensure alignment with the global business, regulatory and scientific strategy, as well as appropriate education for scientific and medical advisors in the markets. You also act as a key resource for the preparation and meetings with regulatory bodies. In addition, you serve as a strategic mentor, leader and senior regulatory science liaison. You ensure the greatest scientific transparency in order to gain recognition as an unbiased source of scientific and medical information in an undefined, highly ambiguous and complex regulatory and scientific environment. Specific responsibilities: Build the Regulatory Scientific Strategy together with and serve as a Science Liaison to the Regulatory Affairs team Ensure that the regulatory science strategy is integrated in the global, regional and local regulatory strategy and aligned with business objectives Accountable for the timely assembly and correctness of the scientific part of regulatory submissions Understand the regional and local regulatory requirement to device the best fitting regulatory science strategy integrating existing local regulatory requirements Understand the latest business and regulatory issues, strategies and guidelines, gain support and adapt the regulatory science strategies accordingly Guarantee that gaps in scientific evidence are reported back to the Management teams to allow the development of a scientific assessment plan as needed Enable markets to meet and discuss scientific results with global, regional and local regulators utilizing the support of scientific Subject Matter Experts and support the regulatory engagement strategy for each market as a key resource Guarantee the scientific and medical soundness of the scientific engagement material used for regulatory purposes to support the development and implementation of a local regulatory framework Supervise Regulatory Science Information Services Act as single point of contact for requests related to regulatory science services or engagement inquiries Ensure that inquiries are addressed in timely manner by Regulatory Sciences and are scientifically and medically sound Be responsible for education related to the Regulatory Science strategy to internal and external leaders, including the Scientific and Medical Advisor community to enable the team providing mentorship to each market. Why work for us? 1) We are international: you work with clients and learn on-the-job from team members from all over the world; 2) We are flexible: your work fits you and not the other way round, thanks to our Flexible work Arrangement Program; 3) We are a certified top employer: we consider our employees to be our strongest asset, and we are developing talent throughout all levels of the organization. And rest assured, as the first multinational company in Switzerland to obtain the Equal-Salary label, for men and women, our competitive salary and compensation package is for all our employees! JOIN A GLOBAL MARKET LEADER Philip Morris International: Building a Smoke-Free Future Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free IQOS product portfolio includes heated tobacco and nicotine-containing vapor products. As of Dec. 31, 2018, PMI estimates that approximately 6.6 million adult smokers around the world have already stopped smoking and switched to PMI’s heated tobacco product, which is currently available for sale in 44 markets in key cities or nationwide under the IQOS brand. For more information, see our PMI and PMIScience websites. PMI is an Equal Opportunity Employer If you wish to contribute to the future of our business and to the new scientific journey of the industry, please apply online. As with many countries, Switzerland has immigration restrictions which will impact the possibility for non-nationals to work in the country. Profiles required for this position may not being specific enough to justify the recruitment of a person outside of Switzerland or countries having agreed upon free movement with Switzerland, please note that in this case a valid Swiss work permit or Swiss or EU-25 EFTA citizenship is required to apply for this position.
  • Contract
    Full-Time
  • Location
    Neuchatel, Switzerland
  • Department
    Science & Innovation
  • Remaining Openings
    1
  • Job ID
    17816
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