Project Manager Product Development

ph3bOffer /b /h3ulliend-to-end ownership: Lead project management for several pharmaceutical products across the full product development lifecycle /lilistrategic influence: Collaborate closely with internal teams and external partners, directly influencing strategic decisions /liliprofessional growth: Plenty of room for personal development /lilidynamic culture: An international pharmaceutical organization with an entrepreneurial environment that actively encourages innovation /li /ulh3bPosition /b /h3pAs a Project Manager Product Development, you will lead product development projects from initiation through market registration, reporting directly to the Head of Product Development. You develop and manage project plans, milestones, timelines, resources and budgets while coordinating multidisciplinary teams and external partners. You oversee activities such as the evaluation and onboarding of new API suppliers, technology transfers, upscaling, process development and validation, and contribute your CMC expertise to lifecycle strategies for commercial products. As the primary contact for regulatory affairs, quality assurance, supply chain, market access and CMOs/CDMOs, you lead project meetings, keep stakeholders informed of progress and risks, and work with them to resolve technical issues. Throughout, you ensure delivery on time and within budget, compliance with GMP/GDP regulations, and alignment with regulatory, quality and commercial requirements, with patient value and operational efficiency at the centre of every decision. /ph3bProfile /b /h3ullibachelor’s or master’s degree in pharmacy, chemistry, or a related scientific field /liliproven track record working within the pharmaceutical industry, preferably in a project management role /liliat least 5 years of experience within CMC development preferably in process or product development /lilistrong understanding of GMP, EMA/FDA regulations, CMC documentation and quality systems. Experience working with CMOs and CDMOs is a must /liliproactive, structured, strong communication skills, and resilient under pressure /lilifluent in English (both spoken and written) /li /ulh3bCompany /b /h3pEurocept Pharmaceuticals is a successful Dutch company that has been active in the pharmaceutical sector since 2001. The company is characterized as a medium-sized business with short communication lines between various departments. Their mission is to bring medicines to the market that facilitate the therapeutic relationship between healthcare providers and patients. The head office is located in Ankeveen, with offices in Paris and Istanbul. /ppDepending on the market and the services provided, Eurocept Pharmaceutical Holding also operates under the well-known brand Lucane Pharma, primarily for rare disease indications. Depending on the product, Eurocept Pharmaceuticals acts as a marketing authorization holder, manufacturer, local representative, distributor, or wholesaler. In all these different areas, Eurocept Pharmaceuticals delivers high-quality products and services while meeting the high expectations of customers and the requirements as laid down in regulations (GMP/GDP). As a wholesaler and manufacturer, the company is responsible for regulatory affairs, quality, pharmacovigilance, production, marketing, sales, and distribution of medicines in many countries worldwide. Eurocept Pharmaceuticals values diversity, and their work environment can be described as informal, dynamic, and entrepreneurial. /ppAn individual assessment is part of the selection procedure. /p /p #J-18808-Ljbffr