Details

Contract

Full-Time

Location

Neuchatel, Switzerland

Department

Life Sciences

Openings

1

Job ID

51569239

Manager Market Expansion Regulatory Support – Neuchatel, Switzerland 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 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 and beyond nicotine future. Your ‘day to day’ As a Manager Market Expansion Regulatory Support you will work closely with and provides support to regions and markets in leading product expansion, post-market reporting and/or submissions, in line with relevant regulatory requirements and internal and external standards, provide support and contribute to preparation of responses to request for information and data from regulatory authorities, provide support and coordinate interactions with affiliates on product regulatory-related matters, closely collaborate internally/externally, as well as provide support to the Central Regulatory Affairs function in defining and implementing regulatory requirements. More specifically, you'll • Be accountable for logistics, preparation (including content), quality check, and delivery of regulatory submissions in new markets, line extension applications, renewals and/or annual reports in line with applicable regulations. Act as liaison with affiliates and internally to ensure that regulatory submissions are complete/prepared following the current standards in a timely manner, as well as that responses to requests from regulatory authorities are complete and timely prepared following the current standards. • Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of regulatory activities, using appropriate EDMS. • Closely collaborate with affiliates and regional functions in handling requests and challenges related to regulatory aspects. Be responsible for change management activities related to commercialized products and to establish clear process and SOPs for post-market regulatory activities. Stay abreast of current and new legislation applicable to RRPs as well with the new RRP developments. Interpret industry or health authority guidance related to submissions and communicates changes. • Ensure that submissions are carried out in accordance with processes/practices and quality systems requirements. Verify that identified potential deviation and related corrective measures are properly reported and implemented. Who we’re looking for • PhD, Bachelor's / Master’s Degree knowledge to fulfil the technical competencies. • Substantial experience in a Regulatory Affairs position ideally in management of pre- and post-market procedures for tobacco and/or pharmaceuticals. • Knowledge of the EU laws and requirements, ICH, other international regulations. Practical knowledge and experience with preparation of high-quality regulatory submissions (content writing). • Excellent organization skills, sound attention to detail, sound ability to work within a multi-functional, multidisciplinary and project-team oriented environment to ensure project / business alignment, as well as to prioritize and handle multiple tasks in a fast-paced and constantly evolving environment. Target driven, results orientated, ability to lead by example, and to focus on productive and high-yield activities. Demonstrated ability to lead complex relationships and integrate diverse business interests. Strong planning, organizational and monitoring skills. • Advanced IT literacy. • Fluent in written and verbal English; very good regulatory writing skills. What we offer Our success depends on the people 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: a smoke-free future. #LIJobs

Apply