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<p>OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases. It operates worldwide through a strong network of international partners and invests its profits in R&amp;D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections. The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.</p><p>For more information, visit the website: ompharma.com.</p>Regulatory Affairs CMC Manager - Geneva<p>We are recruiting a <strong>Regulatory Affairs CMC Manager</strong> at our headquarters and biotech production site in Geneva. Reporting to the Head of CMC, your mission is to provide expertise on regulatory CMC activities for initial registration in the context of development projects and lifecycle activities, while ensuring regulatory compliance of the registered products to the legal requirements, regulatory standards of the markets and internal standards/procedures.</p><p>Your main responsibilities are as follows:</p><ul><li>Ensure the preparation of the CMC part of the regulatory dossier according to current internal procedures and current applicable regulations/guidelines for clinical phase, initial registration and lifecycle activities</li><li>Support the submission of CMC amendments for clinical phases in collaboration with other Regulatory Affairs sub-teams </li><li>For registered products in European countries and Switzerland, define regulatory strategy and lead the submission in collaboration with other Regulatory Affairs sub-teams for CMC topics</li><li>For registered products in other countries, support the submission with other Regulatory Affairs sub-teams for CMC topics</li><li>Manage Health Authority Questions and Post Approval Commitment in collaboration with subject Matter Experts and other Regulatory Affairs sub-teams</li><li>Act as the contact point for technical teams and provide regulatory expertise in the context of projects under your responsibility</li><li>Perform regulatory assessment for change controls related to CMC topics and complete regulatory actions related</li></ul><p>To carry out this mission, we are looking for a person with the following profile:</p><ul><li>Academic degree in the fields of natural sciences, medicine or similar educational background</li><li>At least 5 years of experience in Regulatory Affairs with proven expertise in CMC biotechnology and initial registration of biological products </li><li>Experience in CMC writing of clinical phase dossiers for EU and US territories</li><li>Ideally, experience in development of products administered by nasal route, products issued from fermentation process, combination products and medical devices (class I)</li><li>Fluent in English with good oral skills in French </li></ul><p>You describe yourself as a solution oriented and flexible person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to deal with tight deadlines. You also demonstrate strong adaptability, communication and negotiation skills, and you like to interact with various stakeholders. </p><p>Are you interested in this opportunity? Apply now and join OM Pharma!</p><br>

Regulatory Affairs CMC Manager - Geneva

Descriptif<p> Regulatory Affairs Officer - Nous recherchons pour l'un de nos clients, leader dans le domaine pharmaceutique, un/eSenior Regulatory Affairs Officer pour le marché US.</p> <p> Ce poste fixe est à pourvoir au sein d'une très belle entreprise genevoise au rayonnement international. Il s'agit d'intégrer une équipe dynamique afin d'y apporter votre expérience en qualité de Regulatory Affairs Officer avec un focus sur le marché US. Pour ce poste, possibilité de faire 1 jour par semaine en "remote", 1 jour par semaine en home-office.</p> <p> Vos responsabilités :</p> <li> Mettre en place les stratégies réglementaires en relation avec les équipes transverses</li> <li> Adapter la conformité réglementaire des produits lors d'une modification</li> <li> Coordonner la préparation des soumissions réglementaires lors du lancement d'un nouveau produit ou d'une modification</li> <li> Formuler les réponses aux questions de la FDA</li> <li> Participer à des audits et des inspections afin de garantir la conformité des produits aux normes établies par la FDA</li> <li> Maintenir votre niveau de connaissance des réglementations, directives et tendances du secteur</li> <li> Apporter des conseils réglementaires stratégiques aux parties prenantes internes</li> <li> Tenir à jour les bases de données RA</li> <li> Garantir l'actualisation des procédures du département réglementaire</li> <p> Votre profil :</p> <li> Vous êtes au bénéfice de min 7 années d’expérience dans le domaine des dispositifs médicaux</li> <li> Très bonne connaissance du marché US ( impératif pour ce poste )</li> <li> Connaissance approfondie des normes de qualité (ISO 13485). Connaissance des classes II A, II B et classe III.</li>

Senior Regulatory Affairs Officer pour le marché US.

<h3>Herzlich willkommen bei Medbase Bern Bahnhof<p>In unserem modern eingerichteten Praxiszentrum am Bahnhof Bern bieten wir unseren Patienten und Patientinnen eine qualitativ hochstehende Betreuung und begegnen ihnen mit Kompetenz und Empathie. Unser Team besteht aus rund 45 Mitarbeitenden. Es setzt sich aus Fachärzten/innen und verschiedenen Spezialgebieten wie, Orthopädie, Chirurgie, Gynäkologie, Pädiatrie zusammen. Das ermöglicht einen regen interdisziplinären Austausch der Fachpersonen und eine umfassende medizinische Behandlung der Patienten. Um den Patienten einen Mehrwert bezüglich Angebot und Wartezeiten zu schaffen, bieten wir an 365 Tage im Jahr, einen Walk-In-Notfall an. Mit geregelten Arbeitszeiten und möglichen Teilzeitanstellungen, achten wir auf eine ausgewogene Work-Life-Balance.</p><h3><strong>Ihre Aufgaben</strong><p>Sie betreuen Ihre Patienten ganzheitlich und eigenverantwortlich. In unserem Team von FachärztInnen, AssistenzärztInnen wie MPAs tauschen Sie sich regelmässig aus, sodass ein echter Mehrwert für unsere Patienten geschaffen werden kann.</p><h3>Ihr Profil<ul><li>Sie sind Facharzt/Fachärztin für Allgemeine Innere Medizin (Schweiz oder mit MEBEKO Anerkennung)</li><li>Idealerweise 3-jährige Tätigkeit in der Schweiz</li><li>Sie teachen gerne Assistenzärtinnen und –ärzte (wir sind Weiterbildungskategorie II für Allg. Innere Medizin, 1.5 Jahre) und Wahljahrstudenten</li><li>Sie wollen Patienten umfassend und interdisziplinär betreuen           </li><li>Sie sind teamfähig und arbeiten lösungsorientiert</li><li>Sie beherrschen Deutsch in Wort und Schrift sowie mind. eine andere Sprache</li></ul></h3></h3></h3>

Facharzt Allgemeine Innere Medizin im Walk-in Notfall (w/m/d) 40-100%

<h2> Description du poste</h2>                       As the Regulatory Affairs Specialist, you will play a critical role in enabling the PHC business for the relevant portfolio within and outside Europe. You will coordinate Regulatory Life Cycle Management activities across multiple countries, ensuring compliance with regulatory requirements and maintaining Global Master Dossiers. Additionally, you will provide strategic input into Regional Product labeling and approval to facilitate commercial activation of product launches.  <br>   Your key responsibilities will be:  <br>  <ul> <li> To build medicinal capability within Regulatory Affairs Life Cycle Management and ensure medicinal aspects are integrated into projects, work processes, and systems.</li> <li> To coordinate changes to existing products/dossiers to maintain market presence and compliance.</li> <li> To act as the primary point of contact for local regulatory colleagues, fostering effective communication and collaboration.</li> <li> To maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance.</li> <li> To advise the organization on potential regulatory risks and recommend compliant actions.</li> <li> To ensure regulatory assessments are conducted for change controls in the Veeva Quality Tracking system.</li> <li> To maintain and update the Veeva Regulatory Information Management system for all activities under role responsibility.</li> <li> To contribute to new regulatory policies, systems, and processes to reinforce governance and compliance across LCM and the Regulatory Affairs function.</li> </ul>  <br>                       <h2> Profil attendu</h2>                       Requirements:  <br>   Education: Minimum of a Master's degree in pharmacy, engineering, or chemistry with knowledge in Regulatory Affairs.  Languages: Proficiency in English.  Professional experience: 1-2 years of initial regulatory affairs experience, preferably in consumer health, and across multiple regulatory classification areas.  Motivation: Strong motivation for dossier maintenance and product change management.  Skills: Proficiency in working with complex Regulatory databases; ability to work independently in a matrix environment to build superior relationships with stakeholders.  Initiative: Strong initiative and follow-through with accountability for work quality.  Organizational skills: Ability to handle a complex product-country portfolio with a solution-oriented attitude.  Communication: Excellent attention to detail, good communication, and presentation skills.  Results-oriented: Ability to influence others and drive results.  Adaptability: Openness to change and ability to think outside the box.<br>    If you are a motivated and results-oriented individual with a passion for Regulatory Affairs and a desire to make a difference in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.

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