Regulatory Affairs Consultant
Vor 4 Tagen
Are you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team
The role can be home or office based in various European locations.
**Key Responsibilities**:
- Provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland
- Support national dossier filings and contribute to centralized dossier preparation
- Lead small-scale projects or work streams, ensuring client satisfaction and project success
- Collaborate with cross-functional teams to deliver high-quality regulatory solutions
- University degree in a scientific area
- Several years of experience in regulatory affairs, specifically in German and Swiss markets
- Experience working with Swissmedic and BfArM
- In-depth knowledge of international regulatory requirements
- Strong understanding of EU regulatory landscape
- Excellent project management and client communication skills
- Ability to work independently and as part of a team
- Proactive problem-solver with keen attention to detail
- Fluent English and German speaker (required)
LI-REMOTE
-
Regulatory Affairs Associate
Vor 4 Tagen
Bern, Schweiz InnoMedica Holding AG Vollzeit**INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...
-
Global Regulatory Affairs Intercontinental
Vor 2 Tagen
Bern, Schweiz CSL Behring Vollzeit**Responsibilities**: - Plan, direct, and monitor regulatory affairs activities so the organization has the permits, licenses, certificates, authorizations, and other approvals needed to conduct current and future business activities; and produce, sell, and distribute its goods and services. - Support development of consistent roles and work processes. -...
-
Regulatory & Clinical Affairs Expert
vor 2 Wochen
Bern, Schweiz Guided Solutions VollzeitOur customer is a leading Swiss SME and developer of cutting edge High-Tech Medical Device technology. A disruptor in their field with a strong Engineering core originating at Bern University, though now employing some of the brightest minds in Electronics, Mechatronics, physics and Software development. We have been tasked to identify and recruit a...
-
Regulatory Affairs Manager.
vor 3 Wochen
Bern, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systemsManage the development and implementation of regulatory strategiesSupport and prepare worldwide product submission documentsPartner with...
-
Manager Quality Assurance and Regulatory Affairs
Vor 4 Tagen
Bern, Schweiz Vetoquinol AG Vollzeit**Arbeitspensum: 80-100%** **Ihre Aufgaben**: - Innerhalb eines kleinen Teams sind Sie mitverantwortlich für die GMP Compliance und Zulassungskonformität unserer tiermedizinischen Produkte sowie die GDP Compliance der Lieferkette. - Zudem wirken Sie mit bei allen regulatorischen Zulassungsaufgaben entsprechend den gesetzlichen Richtlinien und den...
-
Global Regulatory Affairs Cmc Scientist in The
Vor 7 Tagen
Bern, Schweiz CSL Behring VollzeitDo you want to work in a global team and support worldwide registrations for Albumins? The Global Regulatory Affairs CMC Scientist is part of a global team of eight responsible for over 150 Albumins licenses in almost 100 countries worldwide. Albumin is manufactured at four CSL Behring sites and contributes significantly to the companies’ revenue. The...
-
Mitarbeiter Regulatory Affairs
vor 2 Wochen
Bern, Schweiz Air Liquide Vollzeit**Unternehmenspräsentation** AIR LIQUIDE** ist ein Weltmarktführer bei Gasen, Technologien und Services für Industrie und Gesundheit. Mit rund 66.400 Mitarbeitern in 75 Ländern versorgt Air Liquide mehr als 3,8 Millionen Kunden und Patienten. Sauerstoff, Stickstoff und Wasserstoff sind kleine Moleküle von grundlegender Bedeutung für das Leben, für die...
-
Regulatory Affairs Manager
Vor 2 Tagen
Bern, Schweiz LHH VollzeitFür unseren Mandanten, ein global agierendes mittelständisches Unternehmen mit über 20 Jahren Erfahrung in der Pharmabranche, suchen wir zum nächstmöglichen Zeitpunkt einen **Regulatory Affairs Manager (m/w/d)**. Unser Mandant zeichnet sich durch flache Hierarchien, ein familiäres Miteinander und eine täglich gelebte Wertschätzung...
-
Regulatory and Clinical Affairs Specialist
vor 4 Wochen
Bern, Schweiz Cascination AG VollzeitYour missionYour Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include:Develop and execute regulatory strategies aligned with business objectivesCreate, submit, and maintain regulatory documentation, including technical files and submissions required for...
-
Regulatory and Clinical Affairs Specialist
vor 4 Wochen
Bern, Schweiz CASCINATION VollzeitYour missionYour Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include:Develop and execute regulatory strategies aligned with business objectivesCreate, submit, and maintain regulatory documentation, including technical files and submissions required for...
-
Bern, Schweiz NZZone VollzeitÜber unsDie BKW bietet ihren Kundinnen und Kunden international Gesamtlösungen in den Bereichen Energie, Gebäude und Infrastruktur an. Wir beschäftigen rund 11'500 Mitarbeitende. Gemeinsam bauen wir Netze, produzieren Energie, planen und realisieren energieeffiziente Gebäude und gestalten nachhaltige Lebensräume von morgen.Dazu brauchen wir Sie:...
-
Regulatory Affairs Manager
Vor 6 Tagen
Bern, Schweiz ROCKEN VollzeitDie ROCKEN Partnerin ist die führende Entwicklerin und Herstellerin von Systemen in der Medizintechnik. Als Innovations - und Technologieführerin ist sie die bevorzugte Partnerin von Pharma - und Biotechunternehmen für Injektions - und Infusionssysteme. Sie präsentiert und vertreibt ihre Produktportfolios unter Dachmarken direkt an Patienten oder über...
-
Regulatory and Clinical Affairs Specialist
vor 3 Wochen
Verwaltungsregion Bern-Mittelland, Schweiz CASCINATION AG VollzeitYour missionYour Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include:Develop and execute regulatory strategies aligned with business objectivesCreate, submit, and maintain regulatory documentation, including technical files and submissions required for...
-
Global Regulatory Affairs
vor 3 Wochen
Bern, Schweiz Swisslinx VollzeitOn behalf of our client, an international Biotechnology company based in Bern, Swisslinx is looking for a GRA Process Excellence & Compliance Scientist. This is a 6-months contract position with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment. - Start date: ASAP - Duration: 6...
-
Regional Regulatory Lead
vor 3 Wochen
Bern, Schweiz TN Switzerland VollzeitRegional Regulatory Lead (m/f/d)Freelance/temporary employment for a project in BernStart date: asapReference number: 768358/1Your responsibilitiesServe as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries.Align all regulatory activities with regional and global strategies,...
-
Regional Regulatory Leader
vor 3 Wochen
Bern, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Regional Regulatory Leader (m/f/d), BernClient: HaysLocation: BernJob Category: OtherJob Reference: 354d2c581067Job Views: 10Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Regional Regulatory Leader (m/f/d)Freelance/temporary employment for a project. Start date: asap. Reference number: 768359/1Your...
-
Clinical-Regulatory Program Manager
vor 2 Wochen
Muri bei Bern, Schweiz Compremium AG VollzeitJob OverviewCompremium is seeking a skilled and highly motivated Clinical-Regulatory Program Manager to join our team. The ideal candidate will have a strong background in clinical and regulatory affairs within the medical device sector and experience in regulatory approval pathways with FDA and EU notified bodies. The successful candidate will ensure the...
-
Bern, Schweiz CSL Behring Vollzeit**Position Purpose**: The Dir., Sr. Global Regulatory Lead, Hematology TA, is a member of a GRA GPS Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as: - ** GRA** Representatives** **on Product/Project Strategy Teams (PSTs), key Delivery Teams (e.g., Clinical Development Teams [CDTs], Safety Management Teams...
-
Regulatory Specialist
vor 4 Wochen
Bern, Schweiz DOLDER AG VollzeitThe Dolder Group is a family-owned international company headquartered in Switzerland, offering chemical specialties, thermoplastic granules, and innovative environmental solutions. With a consultative approach and a global network of partners, we support our clients in enhancing their competitiveness, addressing the demands for sustainability and growth.For...
-
Lead Counsel Regulatory, Safety
Vor 4 Tagen
Bern, Schweiz CSL Behring Vollzeit**Purpose**: Lead counsel responsible for providing and coordinating specialist legal advice on safety and pharmacovigilance matters in CSL’s key jurisdictions, and strategic and specialist legal advice on regulatory matters. **Responsibilities**: - Provide specialist legal advice to CSL’s Global Regulatory Affairs (GRA) and Global Clinical Safety &...