Details

Contract

Full-Time

Location

Neuchatel, Switzerland

Department

Life Sciences

Openings

1

Job ID

31874199

Be 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 the power to improve the lives of a billion smokers worldwide. 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 future, your work could change the lives of a billion smokers. Your ‘day to day’ As a Manager Regulatory Submissions you'll coordinate the submission officers that support all operational activities pertaining to the preparation of regulatory submission documents. You'll also be responsible for submission covering all PMI product categories and all markets where PMI wants to introduce and maintain products. More specifically, you'll • Be responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with regulatory requirements and company standards • Assure completeness and quality of submissions from the operations perspective. Identify issues, suggest and implement solutions under guidance. • Provide regulatory advice and guidance regarding submission requirements and dossier content/structure • Interpret industry or health authority guidance related to submissions and communicate changes • Establish and maintain efficient submission process and manage cross-functional submission projects Who we’re looking for • Degree in life science subject with good knowledge of regulatory processes • Minimum of 5 years of experience in a Regulatory Affairs position ideally for pharmaceutical or other regulated industry, • Experience with regulatory publishing/submissions • Practical knowledge of major regulations and industry standards pertaining to regulatory submissions and publishing for pharmaceutical or tobacco industry • Evidence of working with US and/or EU Regulatory Agencies supporting Regulatory Dossier review and approval processes • Excellent organization skills and sound attention to detail • Basic experience in people management • Ability to work well with others and within global teams • Ability to prioritize and handle multiple tasks in a fast-paced and constantly evolving environment • Proficiency in English, both oral and written What we offer Our success depends on the men and women 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: to improve the lives of a billion smokers. PMI is an Equal Opportunity Employer 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.

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