Regulatory Affairs Manager EU/CH/US

☞ Make A Healthy Change

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Update day: 25-04-2024

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Category: Pharmacist / Pharmaceutical representatives

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In view of our continued global growth, we are looking for further support and recruiting a Regulatory Affairs Manager EU/CH/US based at our biotech production site in 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. Reporting to the Regional Regulatory Affairs Head EU/CH/US, your main responsibilities are as follows:
  • Submit new registrations, renewals & variations in EU, CH and US in coordination with other RA departments
  • Be 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/strategy on submission in EU and/or CH to RA International to ensure timely regulatory activities in other countries where the products are registered i.e. Latam, Apac, MEA…
  • 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.)
To carry out this mission, we are looking for a person with the following profile:
  • Scientific, Pharmaceutical or Medical degree
  • More than 7 years’ work experience in Regulatory Affairs (EU mainly, in CH and US would be an asset)
  • Intercultural competence
  • Fluent in English (both written and spoken), with, ideally, good command of French
You describe yourself as an analytical and result-oriented person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. You also demonstrate strong adaptability, leadership competencies and negotiation skills, and you like to interact with various stakeholders.

Are you interested in this opportunity? Apply now and join OM Pharma!

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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Deadline: 09-06-2024

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