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Senior Officer Regulatory Affairs Heated Tobacco Products – Europe
Are you inquisitive, self-driven and highly motivated? Will you make a difference to our company and your colleagues around you by encouraging collaboration? If the answer is yes, then we’d like to hear from you. We are looking for a passionate individual with a PhD / Master’s Degree in regulatory affairs, natural sciences (e.g. Biology, Lifescience, Engineering) or medical speciality (e.g. Public Health, Pharmacist) and substantial experience in regulatory affairs. You have already been directly involved in the preparation of Marketing Authorization Applications (MAA) in Europe. You are experienced in regulatory submissions for pharmaceutical products and/or medical device development, biopharmaceuticals, botanical drug products, modified risk tobacco products, functional foods, cosmetics. You have a good understanding of applicable regulatory requirements and mindset, the authorization process and structure of regulatory dossiers (for example, the Common Technical Document and Modified Risk Tobacco Product Application). You possess sound knowledge of systems supporting the development and publishing of MAA and other submissions. You have good negotiation/communication (also written) skills and are able to provide technical advice to internal cross-functional project teams (within Regulatory Affairs, Quality Assurance, pre-Clinical/Clinical, Product Development) as well as interact externally with CROs, providers and Health Authorities. In addition you are fluent in English (both written and oral) and are also proficient in Word/Powerpoint/Excel.
RISE TO THE CHALLENGE
Philip Morris Products S.A. is seeking a talented professional to join our Regulatory Affairs Heated Tobacco Products (HTP) team (within Regulatory and Scientific Affairs in Research & Development), based in Neuchâtel – Switzerland, whose objective is to support the development, assessment and commercialization of new products with the potential to reduce the risks* of smoking-related diseases. You will be specifically responsible for regulatory submissions related to PMI's HTPs in a defined region. You will provide technical and scientific leadership to cross-functional teams in order to compile and maintain regulatory dossiers submitted to regulatory authorities. You will also engage with senior management in R&D to provide direction and input on matters related to the regulatory requirements for an HTP in the defined region, as well as supporting local markets in the region defined in terms of submission timelines and interactions with Health Authorities.
- Work in coordination with the Manager Regulatory Affairs HTP to define and implement registration activities for PMI's Heated Tobacco Products (HTP) in defined region, according to PMI's development and launch plan.
- Be responsible for preparation, compilation, quality & scientific check and publishing of RRPs submissions for HTPs in compliance with regulatory guidance/requirements in the defined region and PMI internal standards. Ensure completeness and accuracy of submissions to regulatory authorities in support of assessment studies, market-specific regulatory engagement activities and existing marketing authorizations.
- Ensure compliance and maintenance of all product registrations for PMI's HTPs in the defined region throughout the whole life-cycle of the products.
- Stay abreast of current and new legislation in the defined region. Follow and analyze the applicable regulatory requirements in the region and contribute to the implementation of submission plans and strategies.
- Provide advice to the organization for all regulatory aspects which are of relevance to PMI's HTPs in the defined region.
- Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management and communication with/submission to regulators. Provide input to optimize processes to ensure the development and implementation of electronic systems for effective management of documentation, submissions and archives (Controlled document management system for R&D and Regulatory publishing system and tools).
- Establish strong relationships within R&D and associated commercialization functions in order to ensure alignments between regulatory strategies, product development & assessment and business goals.
FIND A NEW PATH
Our company offers you a new and fresh scientific perspective. Here, you will never stop exploring and discovering. We take on-the-job learning to another level, giving you every opportunity to develop your career and reach your fullest potential. This position will advance your experience with innovative technologies in a highly dynamic environment. Backed by a competitive salary and compensation package, you will work in a professional setting with clients and team members from all over the world.
JOIN A GLOBAL MARKET LEADER
Philip Morris International Inc. (PMI) is the leading international tobacco company, with six of the world’s top 15 international brands, including the number one cigarette brand worldwide. PMI’s products are sold in more than 180 markets. In 2014, the company held an estimated 15.6% share of the total international cigarette market outside of the U.S., or 28.6% excluding the People’s Republic of China and the U.S. PMI is an Equal Opportunity Employer. For more information, see
If you wish to contribute to the future of our business and to the new scientific journey of the industry, please apply
A valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position.
*Reduced Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes. PMI’s RRPs are in various stages of development, and we are conducting extensive and rigorous scientific studies to determine whether we can support claims for such products of reduced exposure to harmful and potentially harmful constituents in smoke, and ultimately claims of reduced disease risk, when compared to smoking combustible cigarettes. Before making any such claims, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate reduced exposure or risk. Any such claims may also be subject to government review and approval, as is the case in the USA today.
PMI affiliates do not accept referrals from employment agencies in respect of the vacancies posted on this site. Should an employment agency take any action in respect of such a vacancy, their actions will have been taken without the request or agreement of any PMI affiliate. No PMI affiliate shall be liable for any fees in such circumstances.
Job ID CH-CF-RD-02571