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Senior Officer Regulatory Affairs Nicotine-Containing Products (NCP) – Europe
Are you an experienced professional with a broad knowledge in regulatory affairs? Do you like leading a wide variety of projects and taking responsibility into your own hands? Do you enjoy working in dynamic cross functional teams? Do you have excellent time management skills, as well as an ability to communicate, negotiate and influence? If the answer to these questions is yes, then we would like to hear from you.
We are looking to recruit a problem-solver who understands how regulatory affairs in healthcare / consumer sectors operate, and can bring an innovative approach to managing regulatory activities in the European Union for Philip Morris International (PMI) NCPs.
RISE TO THE CHALLENGE
Philip Morris Products S.A. is seeking talented professionals to join our Regulatory Affairs NCP team, within the Reduced Risk Products (RRP) division, in our state-of-the-art facilities in Neuchâtel, Switzerland. PMI’s success as a company depends on a talented and diverse workplace: we are the first multinational company in Switzerland to be certified as an equal pay employer for men and women. If you are a qualified candidate, we urge you to apply.
The objective of PMI’s RRP team is to develop and assess products with the potential to reduce the risks of smoking-related diseases. This project is at the core of our business: our aim is that one day all adult smokers who otherwise wouldn’t quit will switch to what we call reduced-risk products, or RRPs. Get to know more about us on www.PMIScience.com .
Our Regulatory Affairs team in RRP work closely with our scientists to translate our latest developments into consumer-driven solutions via effective, efficient and compliant product design and implementing industrial processes to commercialize globally.
As a Senior Officer Regulatory Affairs you will play a key role in finding innovative solutions for increasing the value of our scientific evidence packages, further developing intra and inter departmental collaboration and ultimately improving speed to market.
Provide regulatory guidance on NCPs in the markets of interest, as well as support local markets in the region in terms of submissions and enquiries from regulatory authorities.
Participate in regulated cross-functional activities related to NCPs, including but not limited to: risk management, change management, labelling management, and post-marketing surveillance.
Ensure the timely and accurate preparation, compilation, review and publishing of NCP regulatory dossiers in compliance with local regulatory requirements and PMI’s internal standards, in support of clinical studies, market-specific regulatory engagement activities, and marketing authorizations.
Stay abreast of current and new legislation in the European Union. Follow and analyze the applicable regulatory requirements to provide input on all regulatory aspects of relevance.
Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management.
Establish strong relationships within RRP in order to ensure alignment between regulatory strategies, product development and assessment plans, and business goals.
University degree in regulatory affairs, health sciences or life sciences.
Proven experience in regulatory affairs for therapeutic products (pharmaceuticals, medical devices, or combination products) or other strictly regulated products (functional foods, cosmetics, modified-risk tobacco products) in the European Union. Regulatory experience with drug delivery systems for inhalation is an asset.
Expertise in regulatory submissions in the European Union for therapeutic products, or similar, with knowledge of electronic document management systems for regulatory dossiers.
Excellent writing skills. Proficient in Word/PowerPoint/Excel.
Strong communication/negotiation skills, with internal and external stakeholders.
Fluent in English (both written and oral). Additional European Union languages are an asset.
FIND A NEW PATH
Our company offers you a fresh perspective in a highly motivated and multidisciplinary environment. We take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. This internship will advance your experience with innovative technologies, services, and processes. You will work in a professional setting in close collaboration with experts in disciplines such as computational biology, bioinformatics, genetics, and molecular biology, and have access to cutting-edge multi-omics technologies.
JOIN A GLOBAL MARKET LEADER
PMI is the world’s leading international tobacco company, with six of the world's top 15 international brands and products sold in more than 180 markets. In addition to the manufacture and sale of cigarettes, including the number one global cigarette brand, and other tobacco products, PMI is engaged in the development and commercialization of Reduced-Risk Products (“RRPs”). RRPs is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking. We have a range of RRPs in various stages of development, scientific assessment and commercialization. Because our RRPs do not burn tobacco, they produce far lower quantities of harmful and potentially harmful compounds than found in cigarette smoke. For more information, see www.pmi.comand www.pmiscience.com.
PMI is an Equal Opportunity Employer.
If you match our profile and you are interested in joining our dynamic team of professionals, please apply online.
A valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position.