Regulatory Affairs Manager CIS - Geneva

Location: Switzerland - Meyrin/Geneva

Division: Regulatory Affairs

Company: OM Pharma

Amina Oumeziane

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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 Regulatory Affairs Manager CIS in Meyrin/Geneva. In this position you take care of submissions of new marketing authorizations, maintenance and compliance of existing marketing authorizations and all other regulatory activities for the CIS region.

Your main missions are as follows:
- Creation of robust regulatory strategies based on the good knowledge and appropriate interpretation of guidelines, directives etc. (with the particular focus on EAEU legislation developments)
- Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
- Plans all regulatory activities with the assigned partner companies and ensures timely execution
- Communicates with internal stakeholders such as PV, Quality and other departments to ensure compliance and alignment with agreed partner support levels
- Improves business performance by shortening time to market and speed of product change implementation
- Support GMP inspections of manufacturing sites by competent authorities (i.e. EAEU, Russia, Belarus, Kazakhstan, China inspections)
- Acts as Single Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of OM Pharma and corporate or regional stakeholders. Management of EU and West Balkan countries where partner business is the same as in other CIS countries

The ideal candidate will have a degree in Life Sciences in addition to the following:
- Minimum 5 years of experience in Regulatory Affairs
- Ability to analyze the regulatory requirements (particularly EAEU regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies
- Experience in local Drug Regulatory Affairs in Russia/ CIS country
- Leadership and cross-cultural competences
- Strategic thinking, analytical and result-oriented mindset
- Good command of French and English
- Fluent Russian (native speaker is an advantage)

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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