Regulatory Affairs Manager
vor 2 Monaten
Our client, a leading medical technology company specializing in the development and production of solutions for cancer treatment, is looking for you and your expertise as Regulatory Affairs Manager (m/f/d) for the Berlin location at the earliest possible date.
Here's what our clients offer
Flexible working hours & mobile working Permanent employment contract 30 days vacation Occasion-related paid leave, e.g. for relocation, cancer screening Various health offers, e.g. health insurance health days In-house and external catering options Parking facilities and the option to charge electric cars at employee prices
Your tasks
Creation and maintenance of documentation for the approval of (radio)pharmaceutical products in German and English. Writing and updating texts for product information. Handling national and international approval and renewal procedures and preparing applications for variations. Cooperation with external experts, service providers and authorities in Germany and abroad. Supporting regulatory aspects of change processes and ensuring compliance with drug safety requirements. Supporting drug development from a regulatory perspective. Researching and interpreting relevant laws and regulations in the area of marketing authorization.
Your profile
Completed studies in pharmacy, chemistry, biology or a comparable academic qualification. Experience in the field of regulatory affairs. Competence in the preparation and management of marketing authorization documents in English and in dealing with texts for product information. Fluency in written and spoken German and English. Independent, precise and structured way of working. Confident handling of MS Office, Adobe Acrobat and Internet research tools. Strong communication skills and quick comprehension.-
Regulatory Affairs Manager CTD
vor 2 Wochen
Berlin, Berlin, Deutschland Vality One Recruitment GmbH VollzeitJobbeschreibungAls Regulatory Affairs Manager CTD sind Sie für die Erstellung, Pflege und Prüfung von technischen Dokumenten zur Zulassung pharmazeutischer Produkte im CTD-Format auf Englisch verantwortlich.Aufgabenbereiche:Erstellung, Pflege und Prüfung von technischen Dokumenten zur Zulassung pharmazeutischer Produkte im CTD-Format auf...
-
Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland Planet Pharma VollzeitAt Planet Pharma, we are seeking a highly skilled Regulatory Affairs Specialist to join our team.About the RoleWe are looking for a detail-oriented and analytical individual who can assess CMC changes against regulatory filings to ensure compliance. The ideal candidate will have a strong understanding of regulatory requirements and be able to communicate...
-
Regulatory Affairs Associate
vor 2 Monaten
Berlin, Deutschland STRAGO VollzeitSTRAGO Healthcare is a global consultancy that provides top-tier talent services to leading Healthcare and Life Sciences organizations worldwide. With an in-depth understanding of the distinctive challenges and opportunities inherent in each industry, we specialize in sourcing top-tier professionals who are catalysts for innovation, drive improvements in...
-
Regulatory Affairs Manager
vor 3 Monaten
Berlin, Deutschland Olympus VollzeitIhre Aufgaben The Regulatory Affairs Manager ensures compliance of Digital Unit (DU) products with international regulations, provides regulatory guidance, supports product launch compliance, and maintains expertise in evolving industry standards. Your Key Responsibilites: - Ensure DU products comply with regulatory requirements for US, EU, Japan, and...
-
Assistant International Regulatory Affairs
vor 6 Monaten
Berlin, Deutschland BERLIN-CHEMIE VollzeitNUTZEN SIE IHR POTENTIAL ALS**Assistant International Regulatory Affairs (m/w/d)**: - Standort Berlin Fachbereich Regulatory Affairs Karrierelevel Berufserfahrene Einstiegszeitpunkt ab sofort Vertragsart unbefristet Arbeitszeit VollzeitWir suchen eine motivierte und engagierte Verstärkung für unsere Abteilung International Regulatory Affairs....
-
Specialist Regulatory Affairs
vor 7 Monaten
Berlin, Deutschland MKS Instruments Deutschland GmbH Vollzeit**MKS Instruments Deutschland GmbH*** Specialist Regulatory Affairs (f/m/d) - Berlin- Vollzeit- Feste AnstellungMKS in Berlin is looking for a **Specialist Regulatory Affairs (f/m/d)**: In your role as Specialist Regulatory Affairs (f/m/d) at Atotech Deutschland GmbH you are responsible for all aspects of Global Regulatory Affairs such as for the...
-
Regulatory Affairs Consultant
vor 3 Monaten
Berlin, Deutschland Parexel VollzeitWhen our values align, there's no limit to what we can achieve. 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...
-
Senior / Staff Regulatory Affairs Specialist
vor 6 Monaten
Berlin, Deutschland Stryker Corporation VollzeitAs a Senior / Staff Regulatory Affairs Specialist at Stryker, you will be at the heart of groundbreaking advancements, championing the integration of software-based innovative technology in upcoming product launches for our ENT division (Ear, Nose & Throat). This role uniquely caters to individuals with a background in software and/or regulatory affairs,...
-
Clinical & Regulatory Affairs Specialist
vor 6 Monaten
Berlin, Deutschland Meditrial Europe Ltd. Vollzeit**Company Overview**: Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market...
-
Assistant International Regulatory Affairs
vor 7 Monaten
Berlin, Deutschland Berlin-Chemie VollzeitÜbernehmen Sie gemeinsam mit uns Verantwortung für die Zukunft. Wir suchen eine motivierte und engagierte Verstärkung für unsere Abteilung International Regulatory Affairs. Gemeinsam mit drei weiteren Assistent:Innen sind Sie zuständig für die administrative Unterstützung sämtlicher Aktivitäten zur Erlangung und Aufrechterhaltung von...
-
Studentische/n Mitarbeiter/in Regulatory Affairs
vor 4 Monaten
Berlin, Deutschland Charité Healthcare Services GmbH Vollzeit**Sie haben Interesse an einer Mitarbeit in unserem Unternehmen?**: Dann bewerben Sie sich bitte auf eine unserer Stellenangebote oder initiativ. Ihre aussagekräftige Bewerbung sollte idealer Weise folgende Unterlagen enthalten: - Motivationsschreiben - Lebenslauf - ggf. relevante Zeugnisse und Zertifikate **studentische/n Mitarbeiter/in Regulatory...
-
Regulatory Affairs Specialist
vor 3 Monaten
Berlin, Deutschland GULP – experts united VollzeitHier stimmt die Chemie: Wir vereinen jahrzehntelanges Know-how, digitale Kompetenz und persönliche Beratung mit der Sicherheit und der Expertise eines international agierenden Global Players. Aktuell suchen wir im Kundenauftrag einen Regulatory Affairs Associate für den Standort Berlin . Sie sind Regulatory Affairs Specialist und auf der Suche...
-
Werkstudent Regulatory Affairs
vor 4 Monaten
Berlin, Deutschland Charité Healthcare Services GmbH Vollzeit**Sie haben Interesse an einer Mitarbeit in unserem Unternehmen?**: Dann bewerben Sie sich bitte auf eine unserer Stellenangebote oder initiativ. Ihre aussagekräftige Bewerbung sollte idealer Weise folgende Unterlagen enthalten: - Motivationsschreiben - Lebenslauf - ggf. relevante Zeugnisse und Zertifikate **Werkstudent Regulatory Affairs (m/w/d)**: Die...
-
Clinical & Regulatory Affairs Specialist
vor 7 Monaten
Berlin, Deutschland Meditrial Europe Ltd. VollzeitMeditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals. Since 2008, Meditrial delivers...
-
Director of European Regulatory Affairs
vor 6 Monaten
Berlin, Deutschland Kyverna Therapeutics VollzeitKyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases....
-
Medical Device Compliance Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland Cherry Ventures VollzeitCompany OverviewCherry Ventures is a venture capital firm that supports innovative startups. As a key partner, we help our portfolio companies scale and succeed.SalaryWe offer a competitive salary ranging from €80,000 to €110,000 per annum, depending on experience.Job DescriptionWe are seeking a dedicated Quality Management & Regulatory Affairs Customer...
-
Regulatory Compliance Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland Planet Pharma VollzeitJob Description:This role involves developing and maintaining a solid understanding of regulatory requirements and available guidance documents and resources.The Regulatory Affairs Manager assists with planning, scientific writing, and critical reviews of submissions to ensure conformance with regulatory requirements.Excellent communication skills are...
-
International Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Deutschland Berlin-Chemie AG Vollzeit**Site**: Berlin**Specialist field**: Regulatory Affairs**Career level**: Experienced professionals**Commencement date**: with immediate effect**Type of contract**: Fixed-term**Working time**: Full-timeWithin our International Regulatory Affairs & Drug Safety Department in Berlin, you will be responsible for the acquisition and regulatory management of...
-
Regulatory Affairs Assistant
vor 4 Monaten
Berlin, Deutschland Aristo Pharma GmbH Vollzeit**ARISTO PHARMA** **Regulatory Affairs Assistant - Labelling (m/w/d)****: 11. September 2024 Befristete Anstellung Wir sind ein Team aus mehr als 1.600 Kolleginnen und Kollegen mit der Mission, die Versorgung mit hochwertigen Medikamenten zuverlässig und bezahlbar zu ermöglichen. Aristo Pharma wurde 2008 aus dem Zusammenschluss verschiedener...
-
Referent Public
vor 3 Monaten
Berlin, Deutschland Salzgitter AG VollzeitDie Abteilung Public & Regulatory Affairs ist eine Stabsabteilung der Salzgitter AG und dem Ressort des Vorstandsvorsitzenden zugeordnet. Die Salzgitter AG hat den Anspruch, sich in allen konzernstrategisch relevanten Belangen gegenüber der Politik zu positionieren; sie vertritt dazu ihre Interessen auf regionaler, nationaler und internationaler Ebene....
