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In view of our continued global growth we need to further support the execution of our company strategy. For this reason we are recruiting our new RA Manager EU/CH/US in Meyrin/Geneva. In this position you take care of submissions of new marketing authorizations, maintenance and compliance of existing marketing authorizations for products under your responsibility.

Your main missions are as follows:-Submit new registrations, renewals & variations in EU, CH and US in coordination with other RA departments-Responsible for the designated regulatory projects with respective deadlines: from regulatory assessment to strategy implementation. -Coordinate the responses to Q&A related to pre- and clinical topics and liaise with RA CMC for Q&A related to CMC part -Coordinate the maintenance of up-to-date Module 4, 5 and SmPC/PIL documentation according to international guidelines (EU, FDA, ICH)-Ensure compliance of dossiers with legislation and with the general requirements, particularly in EU, CH and USA (ICH) in liaison with other RA groups-Provide information on submission in EU and/or CH to RA International to ensure timely regulatory activities in RoW countries-Support for development projects under incorporation of regulatory requirements-Interact with Regulatory authorities, affiliates and partners-Be the interface with other departments on national and international levels-Represent regulatory within meetings for products under responsibility-Define and follow budget for products under responsibility-Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc.)

The ideal candidate will have a degree in Scientific or medical degree in addition to the following:-More than 7 years’ work experience in Regulatory Affairs in Europe (in CH and US would be an asset)-Leadership competencies such as product management and diplomacy skills-Negotiation skills-Good command of English and French – both written and spoken-Intercultural competence

Über uns

OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.

It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.

The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.

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