Regulatory Affairs Associate
vor 3 Wochen
Für ein biopharmazeutisches Unternehmen in München suchen wir zum nächstmöglichen Zeitpunkt eine/n
**Regulatory Affairs Associate (m/w/d)**
Supports the activities of the affiliate's Regulatory Affairs team to ensure that the company complies with country's applicable legislations and regulations pertaining to the portfolio (at all stages of the product's life cycle), i.e. ensure that the medicinal products can be developed, authorized and maintained on the market.
Essential Duties and Responsibilities:
- Support local (deputy) representatives (QA/GDP Responsible Person and deputy) as required by local law to support maintenance of GDP license and Quality Agreements as required including but not limited to;
- management of quality complaints, quality defects, falsified or counterfeit products, batch recalls, and stock out as required.
- management of Quality systems inc. data entries.
- maintenance and update of procedural documents
- Support Regulatory Team when required;
- to ensure compliant labeling for the medicinal products and manage timely updates
- to provide operational support to Reg Team with creation, review and release of German Compendia and Basistext (already being supported by a local vendor partially or-ad-hoc)
Knowledge, Experience & Skills:
- preferred: 2-3+ years of experience in Regulatory Affairs (RA) or Quality Assurance (in the field of GDP is preferred) with BS/BA Degree in a scientific field
- Basic knowledge and experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate
- advantageous: Knowledge in promotional and non-promotional review as well as pharmacovigilance and market access
- beneficial: Experience in working with project teams
- Ability to work on a number of projects with tight timelines
- Excellent verbal and written English and German language skills, organization skills and interpersonal communication skills required
Parameter:
- Standort: München (vsl. 3 Tage vor Ort, 2 Tage remote möglich)
- Start: zum nächstmöglichen Zeitpunkt
- Auslastung: Vollzeit (38h/Woche)
Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.
-
Regulatory Affairs Associate
vor 3 Wochen
Munich, Deutschland Progressive Recruitment NL Vollzeit**Regulatory Affairs Associate (m/w/d)** Für ein **globales** **Biotech-Unternehmen** in **München**, suche ich derzeit einen **Regulatory Affairs Associate.** Wenn Sie auf der Suche nach einer **Einstiegsmöglichkeit in die pharmazeutische-Industrie **sind und in **München** wohnen, dann schauen Sie sich die Aufgaben an und kommen Sie gerne auf mich...
-
Regulatory Affairs Director in Ophthalmology
vor 2 Wochen
Munich, Bayern, Deutschland OmniVision GmbH VollzeitOmniVision GmbH, a leading non-corporate ophthalmology company, is seeking an experienced Regulatory Affairs Director. Located in Germany with international presence, the ideal candidate will lead regulatory affairs strategy and compliance across all product lines.About UsWe are a rapidly growing medium-sized company with headquarters in Germany and...
-
Working Student
vor 7 Monaten
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...
-
Working Student
vor 3 Wochen
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...
-
Pta / Cta - Quereinstieg in Regulatory Affairs Als
vor 7 Monaten
Munich, Deutschland Salus Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG Vollzeit**PTA / CTA - Quereinstieg in Regulatory Affairs als Associate in Teilzeit (m/w/d)** - Wir sorgen mit viel Leidenschaft und Engagement dafür, dass unsere Produkte weltweit für unsere Kund:innen zugänglich sind. Wir sind der direkte Ansprechpartner für unsere Exportabteilung, Vertriebspartner und Behörden bei zulassungsrelevanten & regulatorischen...
-
Senior/regulatory Affairs Specialist
vor 3 Wochen
Munich, Deutschland Thermo Fisher Scientific VollzeitWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve...
-
Senior Quality
vor 2 Wochen
Munich, Deutschland Metric Bio VollzeitSenior Quality & Regulatory Affairs Leader – Help Shape the Future of Skin Cancer Treatment!Are you driven to make a real difference in patient care? We’re partnering with a pioneering MedTech dedicated to revolutionising non-melanoma skin cancer (NMSC) treatment. Their non-invasive, painless solutions are transforming the field, and they’re looking...
-
Regulatory Affairs Manager
Vor 6 Tagen
Munich, Deutschland PUREN Pharma GmbH & Co. KG VollzeitDie PUREN Pharma GmbH & Co. KG ist eine deutsche Tochtergesellschaft der international tätigen Aurobindo Pharma Ltd. aus Hyderabad, Indien, mit mehr als 24.000 Mitarbeitern weltweit. Aurobindo verfügt über mehr als 35 Jahre Erfahrung in der Forschung, Entwicklung und Herstellung pharmazeutischer Wirkstoffe und generischer Arzneimittel, die es in mehr als...
-
Munich, Deutschland Marlin Selection Recruitment VollzeitRegulatory Affairs Manager- German Speaking Our client, a commodities firm is looking for a German-speaking Regulatory Affairs Manager to join their team. The role can be remote.Your role will involve:Leading the development and execution of critical objectives that align with the company's strategic goals, secure competitive advantage, and minimize external...
-
Regulatory Affairs Manager
vor 2 Wochen
Munich, Deutschland Melio Life Science VollzeitQuality and Regulatory Manager Are you interested in working with an innovative medical company? My client based in Munich is currently seeking an experienced regulatory manager who has expertise within the FDA submission process. If you enjoy academic discussions, face to face working environments and a highly collaborative team culture then this will be an...
-
Munich, Bayern, Deutschland Metric Bio VollzeitAbout Metric BioMetric Bio is a pioneering MedTech company dedicated to revolutionising non-melanoma skin cancer (NMSC) treatment. Our innovative, non-invasive solutions are transforming the field, and we're seeking an accomplished Regulatory Affairs Strategist to lead our regulatory strategy in Munich, Germany. Salary: €120,000 - €150,000 per year Job...
-
Senior Regulatory Affairs Lead
vor 3 Wochen
Munich, Deutschland Linical Europe VollzeitLinical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan...
-
Director Regulatory Affairs Companion Diagnostics
vor 7 Monaten
Munich, Deutschland Daiichi Sankyo Europe VollzeitResponsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. The job holder provides innovative approaches to resolve complex regulatory issues and increase speed to patients. **Roles & Responsibilities**: - CDx development:...
-
Director Drug Regulatory Affairs
vor 7 Monaten
Munich, Deutschland Weleda VollzeitWeleda ist die weltweit führende Herstellerin von zertifizierter Naturkosmetik und anthroposophischen Arzneimitteln. Für deren Entwicklung, Produktion und Vermarktung engagieren sich international rund 2500 Mitarbeitende. Unsere Produkte tragen ganzheitlich zu Gesundheit und Wohlbefinden des Menschen bei. Zukunftsorientierung, gesellschaftliches Engagement...
-
Regulatory Affairs Specialist
vor 7 Monaten
Munich, Deutschland ADVITOS GmbH VollzeitDie ADVITOS GmbH ist ein innovatives Medizintechnikunternehmen (70+ Mitarbeiter ) mit Sitz in München, das eine vollkommen neuartige Multiorganunterstützungstherapie von der Idee bis zur Marktreife entwickelt hat. Die weltweit patentierte ADVOS-Therapie (ADVanced Organ Support) verbessert die Überlebensrate von Patienten durch zeitgleiche Unterstützung...
-
Regulatory Affairs Specialist
vor 7 Monaten
Munich, Deutschland LivaNova VollzeitJoin us today and make a difference in people's lives! Regulatory Affairs Specialist (M/F/d) Position Summary The Regulatory Affairs Specialist implements and conducts the activities required to obtain and maintain regulatory clearance for the company's medical device products. General Responsibilities - Participating on project teams to provide input to...
-
Assistant Regulatory Affairs
vor 2 Wochen
Munich, Deutschland Jobactive GmbH VollzeitFür unseren Kunden, ein internationales Pharmaunternehmen mit Sitz in München suchen wir ab sofort einen **Assistant Regulatory Affairs (m/w/x) in Teilzeit (20-25 Std. / Woche)**: **Aufgaben und Verantwortlichkeiten**: - Allgemeine administrative Unterstützung des Regulatory Affairs Team, einschließlich allgemeiner Korrespondenz, Reisekostenabrechnung...
-
Scientific & Regulatory Affairs Expert
Vor 6 Tagen
Munich, Deutschland Floy VollzeitScientific & Regulatory Affairs ExpertYOUR MISSIONMedical Scientific Experts play a key role in defining, evaluating, and validating AI medical products, shaping their impact on radiologists' decisions and patient outcomes. You will also ensure regulatory compliance and produce documentation to support product certification and validation.YOUR...
-
Regulatory Associate
vor 3 Wochen
Munich, Deutschland Precision Medicine Group Vollzeit**Position Summary**: To assume regulatory responsibilities including initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) in the assigned country(ies) and ensure compliance with local and international clinical trials regulations and guidelines. **Essential functions of the job include but are not...
-
Remote Regulatory Affairs Manager
Vor 5 Tagen
Munich, Deutschland Kopani Consulting GmbH VollzeitUnser Kunde ist ein international führendes Unternehmen im Bereich Medizintechnik mit Sitz in Frankfurt, das innovative Produkte für den weltweiten Gesundheitsmarkt entwickelt und vertreibt. Zur Unterstützung des Teams suchen wir einen Regulatory Affairs Manager (m/w/d) mit Fokus Technische Dokumentation. Die Stelle ist auch komplett remote denkbar, mit...
