Regulatory Affairs Manager EU/CH/US - Geneva

Location: Switzerland - Meyrin/Geneva

Division: Regulatory Affairs

Company: OM Pharma

Amina Oumeziane

Talent Acquisition Consultant

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About You

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

About Us

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.
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