Regulatory Affairs Manager
Vor 5 Tagen
ob Title: European Regulatory Affairs Manager Location: Munich, Germany - Hybrid, 3x a week in the office Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead several Regulatory Affairs activities for an established generics portfolio. This role will have a main focus on European submissions through MRP, DCP, and National procedures and also support UK and IRE submissions. The position will be responsible for managing regulatory submissions, new registrations, and variations applications for a range of different generic products marketed in the UK, IRE, and Europe. Responsibilities · Manage required regulatory processes for UK and European products including submitting submissions through National MRP and DCP. · Drive all pre-submission meetings including inputting into scientific advice meetings. · Be responsible for all initial/new MAA applications into main EU countries. · Following MA approvals ensure product maintenance including submission of national variations or notifications. · Ensure EU and UK product labelling approval and compliance with the MA approval activities. · Successfully interact with the MHRA and any EU UK Regulatory Authority. Ensuring that regulatory processes are completed, and products are launched in line with regulatory requirements. · Generate and implement local procedures and processes to ensure regulatory compliance is met for EU and UK portfolios. Requirements · Bachelor’s degree or higher in Life Sciences or technical field. · 7 to 10 years of relevant regulatory experience especially within the UK and European markets. Submitting through MRP, DCP and national procedures. · A strong communicator who is able to navigate through difficult conversations with senior stakeholders. · Good team working skills, able to influence to achieve objectives. This position allows for the right candidate to work for a leading generics manufacturer and take charge of UK and European submissions. The role will play a pivotal part in the Regulatory Affairs team and ensure all compliance. The role includes some excellent benefits including a generous bonus scheme. To apply for this role, you must have the full right to work in Europe as this employer does not provide sponsorship. For more information, please contact lucy.kirkaldy@cpl.com
-
Senior Manager/Director of Regulatory Affairs
Vor 5 Tagen
München, Deutschland Cpl Life Sciences Vollzeitob Title: European Regulatory Affairs Manager Location: Munich, Germany - Hybrid, 3x a week in the office Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is...
-
Qm Associate
Vor 3 Tagen
München, Deutschland Brainlab Vollzeit**Company 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 2400 dedicated and inspiring individuals in 25...
-
Teamleitung Regulatory Affairs
Vor 6 Tagen
München, Deutschland TRIGA Consulting GmbH & Co. KG - Internal VollzeitEin international erfolgreiches Pharmaunternehmen sucht in unbefristeter Festanstellung eine*n: **Teamleitung Regulatory Affairs (m/w/d)** Standort: München Homeoffice: 40% **Ihre Aufgaben**: - Leitung eines Regulatory Affairs Subteams - Management der Mitarbeiter durch Weiterentwicklung - Bereuung von europäischen Arzneimittelzulassungen - Kommunikation...
-
Regulatory Affairs Mitarbeiter
Vor 3 Tagen
München, Deutschland TRIGA Consulting GmbH & Co. KG - Internal VollzeitSie möchten Ihre Expertise im Bereich Regulatory Affairs sinnvoll einsetzen und mit Ihrer Arbeit wirklich etwas bewegen? Ein wachsendes, mittelständisches Unternehmen aus dem Bereich Medizintechnik im Großraum München sucht Verstärkung als **Regulatory Affairs Mitarbeiter (m/w/d)**, der Freude daran hat, Verantwortung zu übernehmen und an innovativen...
-
Werkstudent Im Bereich Regulatory Affairs
vor 1 Woche
Garching bei München, Deutschland Edwards Lifesciences Vollzeit**Starte deine Karriere im **Regulatory Affairs** bei Edwards Lifesciences!** **Du bist Student und suchst nach spannenden Herausforderungen in einem flexiblen Umfeld?** Dann bist du bei uns genau richtig! Wir suchen einen **Werkstudenten (m/w/d) in Regulatory Affairs **an unserem Standort in Garching bei München. **Was erwartet Dich?** - ** Mitwirkung...
-
München, Deutschland Triga Consulting GmbH & Co KG VollzeitEin international erfolgreiches Pharmaunternehmen sucht in unbefristeter Festanstellung eine\*n: Teamleitung Regulatory Affairs (m/w/d) **Standort**: München **Homeoffice**: 40% Aufgaben - Leitung eines Regulatory Affairs Subteams - Management der Mitarbeiter durch Weiterentwicklung - Bereuung von europäischen Arzneimittelzulassungen - Kommunikation mit...
-
Trainee (W/m/d) Regulatory Affairs Management
Vor 6 Tagen
81675 München, Deutschland Denk Pharma GmbH & Co. KG Vollzeit**Das macht die Denk Pharma**: Seit 1948 ist die DENK PHARMA als Familienunternehmen in mehr als 80 Ländern tätig. Unter unserem Slogan "Quality for your Health - Made in Germany" schaffen wir für alle Kunden mit unseren Produkten Zugang zur Heilung. Als eines der wenigen Pharmaunternehmen weltweit erhalten alle unsere Kunden genau die gleichen Arznei -...
-
Senior) Regulatory Affairs Expert
vor 23 Stunden
München, Deutschland Ebenbuild Vollzeit**Your mission**: We want you to join our early-stage university spin-off that has just received its ISO 13485 certification. As an integral part of our team, you will harness your regulatory expertise to - develop and implement the regulatory strategy for FDA clearance (De Novo) and conformity assessment under MDR (class II). - create, manage, and maintain...
-
Head of Regulatory Affairs
vor 22 Stunden
München, Deutschland yfood Labs GmbH VollzeitDEINE MISSION - Entwicklung von Zulassungsstrategien für globale Märkte, mit Schwerpunkt auf Europa - Entwicklung und kontinuierliche Verbesserung der internen Prozesse - Berücksichtigung und Umsetzung der nationalen und internationalen Richtlinien im Lebensmittelsektor durch kontinuierliche Überwachung der aktuellen gesetzlichen Regulierungen - Leitung,...
-
Director Global Regulatory
vor 1 Woche
München, Deutschland IDnow VollzeitAt IDnow, we believe innovation is finding solutions to problems that don't yet exist but are sure to impact our future. **Making the connected world a safer place** is and has been our vision from the very beginning. Our **identity verification SaaS solutions enable businesses to make reliable, informed decisions in an instant. We offer robust, secure and...
