Senior Regulatory Affairs Manager
Poste de Senior Regulatory Affairs Manager chez Orion Pharma
Emploi en Finlande
Entreprise : Orion Pharma
Localisation : Espoo, Helsinki
Date d’affichage du poste : 18 juin 2025
Salaire attendu : Non spécifié
Description du poste
Orion Pharma, un acteur majeur du secteur pharmaceutique en Finlande, recherche un Senior Regulatory Affairs Manager pour renforcer son équipe de professionnels en affaires réglementaires. La position est localisée dans les bureaux d’Espoo ou de Turku et s’inscrit dans un modèle de travail hybride.
Responsabilités clés
Les missions principales incluent :
- Renseignements réglementaires : Fournir une expertise stratégique dans le processus de gestion du cycle de vie des produits.
- Conseil réglementaire : Offrir des conseils aux équipes de gestion du cycle de vie des produits.
- Conformité réglementaire : Développer des processus en matière d’affaires réglementaires tout en veillant à la conformité avec les directives GxP.
- Interactions régulatrices : Coordonner les tâches liées aux affaires réglementaires en interne et en externe, en menant les communications et réunions avec les autorités réglementaires et partenaires.
Ce que nous offrons
Orion Pharma propose un environnement de travail enrichissant où les employés peuvent développer leurs compétences. Les collaborateurs bénéficient de formations adaptées et d’une culture organisationnelle fondée sur la bienveillance, le respect et la diversité. Cela favorise l’innovation et l’amélioration de la qualité de vie des clients et de la société.
Exigences
Les candidats doivent répondre aux critères suivants :
- *Diplôme pertinent* : M.Sc. en pharmacie, sciences de la vie ou domaines similaires.
- *Expérience* : Environ 10 ans en affaires réglementaires pour des produits pharmaceutiques.
- *Connaissance* : Législation européenne sur les médicaments et procédures pertinentes.
- *Compétences en communication* : Capacité à travailler en équipe, notamment dans un contexte international.
- *Langues* : Anglais courant, le finnois étant un atout.
Candidature
Les intéressés peuvent soumettre leur lettre de motivation et CV via le système de recrutement d’Orion d’ici le 30 juin 2025. Pour plus d’informations, veuillez contacter Hanna Mäkiniemi, Responsable des affaires réglementaires mondiales.
Considérations éthiques
Il est important de souligner que, pour ce poste, une examen médical incluant des tests de dépistage de drogues est requis avant l’embauche. De plus, une vérification de sécurité sera effectuée sur le candidat sélectionné. Ces mesures se justifient dans le cadre de la protection de la santé publique et de la sécurité au travail.
À propos d’Orion Pharma
Orion est une entreprise pharmaceutique finlandaise d’envergure mondiale, active depuis plus de 100 ans. Elle se distingue par son engagement envers le bien-être et la responsabilité d’employeur. Orion développe, fabrique et commercialise des médicaments humains et vétérinaires, avec un portefeuille diversifié allant des médicaments propriétaires aux génériques, tout en se concentrant sur les domaines thérapeutiques tels que l’oncologie et la gestion de la douleur.
Cette annonce offre une claire opportunité pour les professionnels de régulation intéressés par un environnement dynamique et international. Il est conseillé aux potentiels candidats de se préparer en conséquence afin de maximiser leurs chances de succès dans ce processus de recrutement.
📅 Date de publication de l’offre : Wed, 18 Jun 2025 23:08:34 GMT
🏢 Entreprise : Orion Pharma
📍 Lieu : Espoo, Helsinki
💼 Intitulé du poste : Senior Regulatory Affairs Manager
💶 Rémunération proposée :
📝 Description du poste : Job Description:About your roleWe are looking for an experienced Senior Regulatory Affairs Manager to join our team of regulatory professionals in Orion’s Global Regulatory Affairs, Product Lifecycle Management in Finland.As a Senior Regulatory Manager your role at Orion Pharma Headquarters is to develop and implement regulatory strategies, lead the regulatory submissions during lifecycle management, and provide regulatory guidance to cross-functional teams for Orion´s human pharmaceutical products. You will be part of regulatory professionals working in product lifecycle management process reporting to Head of Global Regulatory Affairs, LCM.The role is permanent and located in Espoo or Turku office in Finland. follow Orion’s hybrid mode of working.Your key responsibilities
- Regulatory Intelligence: provide strategic regulatory expertise in product lifecycle management process.
- Regulatory Guidance: provide regulatory guidance to the product lifecycle teams
- Regulatory Compliance: develop regulatory affairs working processes and ensure that GxP practices, regulatory procedures, systems and processes are managed in compliance with relevant guidelines
- Regulatory Interactions: coordinate regulatory affairs tasks internally and externally. Lead communications and meetings with regulatory authorities and partners. Lead cross-functional teams or act as a regulatory affairs representative in cross-functional teams and/or projects.
What we offerA challenging job and exciting tasks with a large and worldwide product portfolio. Collaboration with various internal and external organisations as well as international working environment. Supportive working environment and training as needs. You have the possibility to develop your competences, learn new skills or improve your skills and strengths. We offer you dynamic and result oriented work community in close co-operation with business.At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.Please visit our website to find further information about our values and Orion as an employer .Our expectationsWe expect you to have:
- Suitable educational background, M.Sc. in Pharmacy, Life Sciences or similar
- Approximately 10 years experience in regulatory affairs for pharmaceutical products (Marketing authorisation applications or variations)
- Knowledge of European regulatory legislation for pharmaceuticals, guidance and procedures for medicinal products and interest in the changing environment
- Excellent communication and team working skills in international relationships
- Proactiveness and solution-oriented mindset, decision making and personal leadership skills
- Fluent written and spoken English skills. Fluent Finnish language skills are a strong advantage.
How to apply and additional informationAre you interested in this opportunity? Please submit your cover letter and CV to Orion recruitment system by June 30th, 2025.For additional details please contact Hanna Mäkiniemi, Head of Global Regulatory Affairs, LCM via phone 050 966 7406. Available on Tuesday June 24th at 15-16 or on Friday June 27th at 8.30 -9.30.We typically review applications already during the application period and may start interviewing candidates before the application deadline. Therefore, we invite you to send your application as soon as possible. Due to summer holiday season the recruitment process takes longer time than normally.Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.Unit descriptionOrion’s Global Operations covers the entire pharmaceutical manufacturing process, from sourcing of raw materials to the manufacture of products, packaging and delivery to customers. We are also responsible for the industrialization of new products and product life cycle management.In Global Operations we have approximately 1,600 professionals working in Production, our external supplier network (Externally Sourced Operations) and Fermion Oy (API manufacturing and marketing). In addition, the organization includes Supply Chain & Procurement, Technical Operations, Facility Management, EHS (Environment, Health and Safety), CPD&LCM (Commercial Product Development & Product lifecycle management) and Operations Development.Global Regulatory Affairs, LCM department is part of Commercial Product Development and Lifecycle Management in Orion Global Operations. Responsibilities of the department relate to regulatory affairs tasks of Orion Branded and Generic Products covering the whole lifecycle of the products after the development phase. Global Regulatory Affairs, LCM has approximately 20 regulatory professionals in Finland who work in the regulatory field of product lifecycle management activities together with our Mumbai office regulatory colleagues, local subsidiaries and regulatory consultant network.#LI-ORIONAbout Us:Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years.Orion provides meaningful work for more than 3 600 Orionees in Finland and abroad. Orion is known as a responsible and reliable employer where we value each other, strive for the best and build for tomorrow.We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others.
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