Notre client développe et produit des médicaments génériques afin d’offrir des médicaments européens de qualité à des prix abordables. Pour notre client, nous sommes à la recherche d’un agent expérimenté en affaires réglementaires (RA) pour rejoindre l’équipe des affaires réglementaires.
Les Responsabilités
Évaluer les spécificités et les exigences réglementaires des marchés européens associées à la soumission du portefeuille sur ces marchés.
Définir la stratégie d’enregistrement des nouveaux produits.
Compiler, rédiger et soumettre les dossiers.
Gérer les communications avec les autorités réglementaires.
Contribuer et/ou coordonner le développement de l’emballage.
Examiner les documents de commercialisation des produits pour s’assurer de leur conformité avec les revendications du produit.
Suivre et communiquer les exigences réglementaires dans l’UE afin d’assurer la préparation des prochaines soumissions.
Soutien technique et formation :
Fournir une expertise technique aux équipes de projet.
Organiser des formations sur les exigences réglementaires européennes à l’intention des équipes internes.
Fournir des mises à jour régulières sur l’avancement du projet aux parties prenantes internes.
Connaissances et Compétences requises
Diplôme supérieur en life sciences (médecine vétérinaire, toxicologie, pharmacie, chimie, etc.) ou équivalent.
Expérience préalable dans le domaine des affaires réglementaires en Europe (minimum 5 ans)
Connaissance approfondie de l’environnement réglementaire, des lignes directrices et des pratiques des régions EMEA.
Une expérience dans le domaine des médicaments génériques est un atout.
Bonne capacité de planification et d’organisation
Solides compétences en communication interpersonnelle (orale et écrite).
Parfaite maitrise de l’anglais et du français exigé (Vous serez mené à être en contact avec des intervenants internationaux au quotidien)
Notre Offre Vous êtes à la recherche d’un nouveau défi ? Jefferson Wells vous accompagne dans chaque étape de votre processus pour un accompagnement personnalisé et qualitatif. Des questions ? Veuillez contacter directement Aylin Ugurlu à l’adresse suivante : [email protected]
Execution of project management activities, including
Contract management for external parties
Managing project scope
Managing project planning (resources and material)
Controlling time management and monitoring progress
Drafting and controlling project budget
Analyzing and managing project risks
Governance & Reporting
Putting in place an effective governance
Managing reports and other necessary documentation
Ensuring internal and external stakeholders’ satisfaction
Leading project’s meetings
Coaching, mentoring and knowledge management
Organizing and motivating a project team
Developing project management best practices
Managing integration of the team’s work to the strategic objectives of the company
Drafting and sharing lessons learned
Who are you ?
A Master’s degree in business, engineering or life sciences is highly preferred.
5 years of experience in a Project Management role, or related function, within Pharmaceutical Industry or its providers. Previous experience in R&D projects is a plus.
Experience of working with global, multi-cultural, diverse, cross-functional project teams, with demanding timelines and complex deliverables
Project Management Certification or Qualification is an asset (PMP, Prince 2, Agile …).
Fluent in English. Fluency in French is a big plus.
Thorough familiarity with word processing, spreadsheet, and project scheduling computer applications.
Ability to manage multiple priorities under pressure, trouble-shoot, and to meet short- and long-term deadlines.
having a customer-centric approach when managing client projects
Agility to transition on an easy way between internal R&D and client/customers R&D projects.
Demonstrated experience in budget and financial management.
Excellent written and verbal communication skills.
Excellent critical and creative thinking.
Ability to build a trusting and safe environment where problems can be raised without fear of blame, retribution, or being judged, with an emphasis on conflicts and problem-solving.
Providing all support to the team using a servant leadership style whenever possible and leading by example
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Our partner is looking for an Product Managerto join its teams.
Your responsibilities?
As a Product Manager, you will have the responsibility of several product lines for biomanufacturing, with a focus on their software platform and Industry 4.0 vision. You will have the mission to define, advance and promote innovative products and software bringing significant benefits to our target markets, in line with the company’s strategic objectives.
RESPONSIBILITIES
Generate and execute the product strategy:
Develop a holistic strategy vision and roadmap combining automation, business information, and manufacturing execution architecture to drive our product portfolio towards Industry 4.0
Create and maintain a comprehensive software offering across the equipment portfolio
Work with commercial, technical and strategy leaders to develop and maintain a centralized product vision and strategy for planning and execution of new products, translating into product roadmaps, requirements, and specifications
Conduct and communicate market research and competitive analysis to drive decision-making. Develop critically justified business cases for new product development.
Articulate and document product value proposition with heavy emphasis on quantitative rationale
Define, monitor and adapt pricing strategy and profitability
Work with marketing and sales to define product positioning and commercialization strategy
Active portfolio management:
Define and implement the life cycle roadmap of current products, in line with corporate objectives and with the current and future portfolio
Monitor technical and commercial performance of the products, continuously identifying and prioritizing improvement opportunities
Define annual product/portfolio priorities and objectives in line with corporate objectives, to be deployed in sales and marketing plans and campaigns
Support creation of tools to navigate the existing portfolio
Be the Life Sciences market expert:
Communicate internally and externally to educate on and promote your product lines, e.g. application notes, webinars, conference presentations
Maintain current knowledge of market trends, competitive landscape, and events of note.
Let's talk about you !
Master and/or Engineering degree. Most preferred degrees are Automation, Bioengineer, Biotechnology, Bioprocessing or any alternative Master / Engineering degree with relevant experience
2+ years of experience as a Product Manager
4+ years of experience in manufacturing industry, ideally in life sciences (pharma, biopharma, food & beverage bioprocessing, medical device) or other regulated industry
Comprehensive understanding and experience in digital technologies, e.g. Internet of Things (IoT), AI, Edge and Cloud computing
Experience or knowledge with Industry 4.0, Digitalization, and software platforms, preferably applied to bioprocessing for biopharma
Strong understanding of portfolio management concepts including life cycle strategy, new product definition, and portfolio rationalization analysis
Knowledge of biological processes, biopharmaceuticals technologies, GMP for biological products would be appreciated
Excellent level of written and spoken English, French is a plus
Our offer?
We offer a long-term contract, a competitive salary package including company car and bonus, an wide array of extra legal advantages and the possibility of evolution in an international, dynamic and fast-growing company.
You’re interested in this job? We kindly invite you to apply.
