Clinical & Regulatory Consultant / PMTA Lead to Emplicure

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<p>Emplicure is a Swedish growth-stage company developing next-generation nicotine pouches based on a proprietary, patented technology platform. The company combines a strong scientific foundation with experienced commercial leadership from the modern oral category. The company is now preparing entry into the US market through the FDA’s PMTA process. To take lead for this process they are looking for a Clincal &amp; Regulatory consultant to join them as PMTA Lead.</p><h3>About the assignment</h3><p>You will lead the company's Premarket Tobacco Product Application (PMTA) from start to finish.</p><p>After two years of preparation, the PMTA programme is planned and execution starts in December. The company now needs one person who owns delivery: who leads the internal team and the external partners, produces plans and documents hands-on, and keeps cost and progress under tight control. </p><p>The company works with experienced US regulatory, legal and scientific consultants who represent it towards the FDA. </p><h5>Key responsibilities:</h5><ul><li><p>Own the integrated PMTA plan, timeline and risk log, and lead the programme from kick-off to submission and FDA follow-up. </p></li><li><p>Lead external partners cost-efficiently: Direct the US consultants, CROs and laboratories with clear briefs, defined deliverables and right-sized meetings. Use external expertise where it adds value, not as a substitute for in-house capacity. </p></li><li><p>Budget and cost control: Track spend continuously against the approved budget, and report budget, costs and forecasts to the CFO on a regular basis. Flag deviations early, with proposed actions. </p></li><li><p>Clinical programme: Drive execution of the planned clinical programme, including pharmacokinetic (PK) studies: CRO management, protocols, ethics/IRB approvals, recruitment, data management and study reports. </p></li><li><p>Nonclinical programme: Lead chemistry, HPHC and stability testing with accredited laboratories. </p></li><li><p>Write plans, protocols input and PMTA sections directly, and coordinate the full dossier (product description, chemistry, toxicology, clinical and consumer data, manufacturing, labelling, marketing, environmental assessment) with review, approval and version control.</p></li></ul><h5>Requirements:</h5><ul><li><p>University degree in life science, pharmacy or chemistry.</p></li><li><p>Proven leadership of complex regulatory submissions from plan to submission, with multiple internal functions and external partners.</p></li><li><p>Track record of managing external consultants and suppliers to budget, with regular financial reporting.</p></li><li><p>FDA regulatory experience, including hands-on work on FDA submissions and FDA interactions.</p></li><li><p>Clinical study experience, including studies run through CROs, protocols, ethics approvals and study reports.</p></li><li><p>Proven ability to write regulatory documentation personally, not only to coordinate it.</p></li><li><p>Fluent professional English, written and spoken. Swedish is not required.</p></li><li><p>Able to invoice as a consultant through own company or consultancy.</p></li></ul><h5>Highly valued, not required:</h5><ul><li><p>PMTA experience.</p></li><li><p>Experience from the nicotine or tobacco industry.</p></li><li><p>PK study experience, ideally in nicotine, tobacco or other oral/inhaled delivery products.</p></li><li><p>Experience of working with US-based regulatory consultants.</p></li><li><p>Experience from a small or scale-up company where commercial and regulatory priorities must be balanced.</p></li></ul><h5>Additional information:</h5><ul><li><p>One or two trips to the US may be needed.</p></li><li><p>Timing matters because of the FDA timeline, with a key milestone at the end of January.</p></li><li><p>This is a consultancy assignment via SallyQ.</p></li></ul><h3>Apply</h3><p>We are reviewing applications on an ongoing basis, so don’t wait to send in yours. If you have any questions, you are very welcome to contact Anna Tara Persson, Recruitment coordinator and recruiter at SallyQ (annatara.persson@sallyq.se).</p>

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