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Regional Head Regulatory Affairs
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Regional Head Regulatory Affairs
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 Scientific Degree, MSc or equivalent in a medical speciality (e.g. pharmacy, clinical pharmacology, biology) and a substantial experience in regulatory affairs (in the pharma, medical devices or food industry) with direct experience leading registration strategies and direct interaction with regulatory authorities for successful new product applications, approvals and post-marketing changes. You are able to influence changes in broader technical/policy issues, worked already at senior manager level and have a record of effectively leading teams. You possess good knowledge of QMSs and pharmacovigilance. You possess internal consulting and project management skills, are able to provide advice to senior management to impact product and policy decision-making, and able to co-ordinate efforts of others across the organization as appropriate on major projects (including internal or externally contracted resources). You are able to provide technical leadership to project teams, are able to interact externally with regulatory/government authorities and internally at Director-level with colleagues in Research & Development and with cross-functional teams across PMI. You are also proficient in Word, Powerpoint, Excel and are are fluent in English (both oral and written).
RISE TO THE CHALLENGE
Philip Morris Products S.A. is seeking a talented professional to join our Regulatory Affairs team (within Research & Development), based in Neuchâtel – Switzerland, whose objective is to support the development and assessment of new products with the potential to reduce the risks* of smoking-related diseases. You will lead respective Affiliates in the region and direct all activities related to the development and implementation of regulatory strategies for NGPs to obtain registrations. You will also provide direction to the Central Regulatory Affairs function in order to establish registration requirements and define submission strategies, as well as work closely with Marketing and Sales to understand market prioritization for registration purposes and with Corporate Affairs in the local market to implement registration strategies. You will develop/maintain a network of relationships within the relevant regulatory authorities at the national levels in support of PMI's commercial objectives in the region, engage with senior managment across PMI to provide direction/input on matters related to the regulatory requirements for MRTP-NCPs and ensure on-going products compliance of the RRP portfolio marketed in the region.
- Develop and lead registration strategies in the region to ensure timely registrations for RRP.
- Develop and lead the registration strategies as required for other novel products in the region.
- Ensure timelines for regulatory clearance for product launches and priorities in the region are met.
- Ensure on-going regulatory product compliance of the RRP portfolio marketed in the region.
- Provide regulatory oversight and support to Product Development and R&D efforts in the development across PMI’s RRP platforms by participating and leading regulatory input into cross-functional project teams.
- Effectively manage relationships with the Regulatory Affairs group within PMI and relationships with regulatory authorities, where necessary, to ensure PMI regulatory applications are strategically aligned with regulators’ expectations.
- Provide leadership to the central Regulatory Affairs function in defining and implementing the registration activities in support of product registrations.
- Recruit and develop and maintain high caliber regulatory professionals to support individual country RA activities.
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-02563