Technical Product Leader – Oral and Semi-solid product portfolio (80% cosmetic – 20% drug) - M/F

Job description

Avec un héritage unique en dermatologie ainsi que des décennies d'innovation de pointe, Galderma est le leader émergent de sa catégorie dédié entièrement à la dermatologie, présent dans environ 90 pays. Nous proposons un portefeuille innovant, basé sur la science, de marques phares haut de gamme et de services qui couvrent l'ensemble du spectre du marché de la dermatologie en pleine croissance grâce à l'esthétique injectable, les soins dermo-cosmétiques et la dermatologie thérapeutique. Depuis notre création en 1981, nous avons consacré notre attention et notre passion à l'organe le plus grand du corps humain - la peau - en répondant aux besoins individuels des consommateurs et des patients avec des résultats supérieurs, en partenariat avec les professionnels de la santé. Parce que nous savons que notre peau façonne l'histoire de notre vie, nous faisons progresser la dermatologie pour chaque histoire de peau. Nous recherchons des personnes qui se concentrent sur l'obtention de résultats, ont envie d'apprendre et apportent une énergie positive. Ils doivent allier initiative, esprit d'équipe et de collaboration. Avant tout, ils doivent être passionnés par l'accomplissement de quelque chose de significatif pour les consommateurs, les patients et les professionnels de la santé que nous servons chaque jour. Nous visons à responsabiliser chaque employé et à favoriser leur développement personnel tout en veillant à ce que les besoins de l'entreprise soient satisfaits maintenant et à l'avenir. Dans notre entreprise, nous encourageons la diversité et respectons la dignité, la vie privée et les droits personnels de chaque employé. Chez Galderma, nous donnons activement à nos équipes des raisons de croire en notre ambition affirmée de devenir la première entreprise de dermatologie au monde. Avec nous, vous avez l'opportunité exceptionnelle d'acquérir de nouvelles expériences professionnelles enrichissantes et de créer un impact direct et sans précédent. has context menu Job title : Technical Product Leader – Oral and Semi-solid product portfolio (80% cosmetic – 20% drug) Job location : Alby sur Chéran (France) Job Description: Lead and coordinate technical and regulatory activities from early stage (i.e. candidate selection) to approval of a product (end to end) in accordance with the Global R&D strategy and in accordance with the company’s quality system, international standards and regulatory requirements. Products in scope are semi-solid (95%) and oral products, with a status of drug product (20% pharmaceutical / OTC) or cosmetic product (80%) Responsible to define, implement and lead the activities for new product development and life cycle management on current products of Galderma portfolio Contribute to Galderma's short- and long-term growth Interact with stakeholders locally as well as with global positions Ensure activities are in line with the global strategies and plans, and compliant with applicable regulatory requirements, quality system and international standards. Report to CMC Semi-solid & Oral Product Science Leadership Manager Key responsibilities: Prepare and deliver strategic recommendations to core teams, projects leaders and the business. The recommendations should be based on the technical and scientific knowledge of the End to End Product leadership team. Lead and decide on the development and implementation of methods, working procedures and documentation needed to fulfill the areas of appointed responsibilities. Lead and coordinate sub-teams and appropriate technical cross-functional workstreams to define and implement the CMC / development strategy and plan Represent the sub-team in the Core Team, and be the project point of contact for other departments, divisions and external partners to ensure alignment on strategy, activities and timelines Ensure the execution of the CMC / development plan according to the Global Integrated Project Plan (strategy, timelines, budget, risks and mitigation) Coordinate the identification of risks, escalade issues, and propose with technical cross-functional teams and appropriate stakeholders’ mitigation plans Support writing, reviewing and filing of regulatory documents (CMC sections for pharmaceutical products / PIF for cosmetic products) and associated documentation (INDs, CTAs, IMPDs, BLAs, Technical files and PAIs…) Support regulatory teams to answer competent authorities’ questions that could be raised during dossier evaluations Ensure liaison and coordination with plants (i.e. MS&T, Supply Chain, laboratory…), notably when transferring a project to the late stage of development When outsourcing is required, work closely with Development, Procurement and Alliance Management representatives to oversee supply and technical agreements Maintain current awareness of guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future product developments Contribute on purpose to due diligence, scientific assessment of external opportunities and divesting projects Skills & Qualifications: Pharm-D / Engineer / PhD or master’s degree in pharmaceutical sciences, cosmetics, chemistry, biology or a related field. 10 years’ experience in cosmetic industry experience, with a minimum of 5Y working in activities supporting worldwide semi-solid product development Significant experience in project management Demonstrated understanding of cosmetic products (formulation, process and/or analytical development, registration). Experience in drug product development and in oral dosage forms would be appreciated In-depth knowledge in developing and implementing risk management Demonstrated experience in setting and developing external partnerships: suppliers, CDMO, CRO, academic Fluency in English, good level in French would be appreciated What we offer in return You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. In addition, we want to ensure our commitment towards equity and inclusion by offering a competitive and fair compensation with a bonus structure and benefit package. You become part of a hybrid culture to ensure innovation and collaboration together with the right work-life balance. You will have a development plan, during which a personalized career path will be established, and you join a growing organization that believes in ownership from day one where everyone is empowered to grow and to take on accountability. Next Steps Please send your CV in English and after positive review, a first virtual conversation with Talent Acquisition will take place (FYI: just need to upload CV, can ignore the manual fields requested after uploading CV) The next step is a virtual conversation with the hiring manager The final step is a panel conversation with the extended team Our people make a difference At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.