Regulatory Affairs Manager
vor 4 Wochen
ob Title: European Regulatory Affairs ManagerLocation: Munich, Germany - Hybrid, 3x a week in the officeRemuneration: Competitive salary and packageRegulatory 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
-
Regulatory Affairs Manager
vor 2 Wochen
Greater Munich Metropolitan Area, Deutschland SymBio. VollzeitRegulatory Affairs Manager (m/w/d) – München - MedizintechnikFür einen international tätigen Medizintechnikhersteller aus München suche ich zum nächstmöglichen Eintrittstermin einen Regulatory Affairs Manager (m/w/d) in unbefristeter Festanstellung.Ihre Aufgabenfelder:Durchführung nationaler und internationaler Zulassung von aktiven Medizinprodukten...
-
Regulatory affairs
vor 2 Wochen
Munich, Deutschland S3 Science Recruitment VollzeitRegulatory Affairs Specialist – CMCLocation: Germany (Hybrid / On-Site)Employment Type: PermanentOverviewWe are seeking an experienced Regulatory Affairs Specialist with strong CMC expertise to join our growing team. This role is ideal for someone with a rigorous scientific background (Master’s or PhD required) and hands-on experience supporting...
-
Associate Regulatory Affairs
Vor 5 Tagen
Munich, Deutschland Daiichi-Sankyo Europe Vollzeit**Passion for Innovation. Compassion for Patients.**: ***Associate Regulatory Affairs - EU Regulatory Procedural Management (M/F/x)**: **The position**: Provide support for EU Regulatory Procedural Management for assigned projectsincluding all pre - and post-authorisation activities ensuring a smooth run of regulatoryprocedures as well as regulatory...
-
Senior Regulatory Affairs Manager
Vor 7 Tagen
Munich, Bayern, Deutschland Cube4 Consulting VollzeitSenior Regulatory Affairs Manager (m/w/d)München | Vollzeit | Ab sofortFokus: Zulassungsverfahren, Dokumentation & regulatorische SystemeÜber unsCube4 Consulting ist dein Partner für gezielte Karriereentwicklung und passgenaue Recruiting-Lösungen.Wir begleiten Fach- und Führungskräfte beim nächsten Karriereschritt – diskret, persönlich und...
-
München + Homeoffice: Regulatory Affairs Manager
vor 4 Wochen
Munich, Deutschland Triga Consulting GmbH & Co KG VollzeitSie möchten etwas bewegen und sich außerdem fachlich und persönlich weiterentwickeln? Unser Kunde ist ein international erfolgreiches Pharmaunternehmen mit marktführenden Produkten. In unbefristeter Festanstellung suchen wir eine/n: Regulatory Affairs Manager (m/w/d) Standort: München Homeoffice: 2 Tage pro Woche Aufgaben Eigenverantwortliche Betreuung...
-
München + Homeoffice: Regulatory Affairs Manager
vor 2 Wochen
Munich, Deutschland Triga Consulting GmbH & Co KG VollzeitSie möchten etwas bewegen und sich außerdem fachlich und persönlich weiterentwickeln? Unser Kunde ist ein international erfolgreiches Pharmaunternehmen mit marktführenden Produkten. In unbefristeter Festanstellung suchen wir eine/n: Regulatory Affairs Manager (m/w/d) Standort: München Homeoffice: 2 Tage pro Woche Aufgaben Eigenverantwortliche Betreuung...
-
Working Student in Regulatory Affairs
vor 2 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 1400 dedicated and inspiring individuals in 19 offices...
-
Working Student in Regulatory Affairs
Vor 3 Tagen
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 1400 dedicated and inspiring individuals in 19 offices...
-
Regulatory Affairs Expert
vor 1 Woche
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...
-
Regulatory Affairs Specialist
vor 1 Woche
Munich, Deutschland OPTARES Gmbh & Co. KG Vollzeit**[**5840**]**: Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put...
