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Regulatory Affairs CMC Specialist - CDD 6 months - Geneva

Location: 

Meyrin, Geneva, CH

Division: 
Division:  Regulatory Affairs
Job Type:  Limited-contract

        

In view of our continued global growth, we are recruiting a Regulatory Affairs CMC Specialist based at our headquarters and biotech production site in Geneva, for a 6-months fixed-term contract. Reporting to the Regulatory Affairs Chemistry Manufacturing and Control (CMC) Team Lead, your mission is to ensure availability of CMC-documentation in order to maintain existing registrations, as well as updating the Regulatory Information Management System. This position is accessible to recent graduates without previous work experience. 


Your main responsibilities are as follows:

  • Prepare CMC documentation and CMC-related documents for lifecycle activities such as Marketing Authorization Renewals and answer to Health Authority Questions 
  • Update Regulatory Information Management System 
  • Set up and test Regulatory Information Management System workflows to automatize certain tasks

 

To carry out this mission, we are looking for a person with the following profile:

  • Educational background in the field of Life Sciences (Bachelor’s, Master’s, PharmD)
  • Good understanding of Regulatory Affairs and CMC role
  • Fluency in English, with, ideally, good oral skills in French

 

You describe yourself as an analytical and solution-oriented person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to deal with tight deadlines. Endowed with a strong team spirit, you also demonstrate good communication skills and intercultural competencies, which allows you to interact efficiently with various stakeholders. 

 

Are you looking for a first experience in CMC within a vibrant and innovative company? Do not miss this opportunity and join OM Pharma!
 

 

About Us

OM Pharma is a global Geneva-based biopharmaceutical 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 invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections. 
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

For more information, visit the website: ompharma.com.

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.
For more information, please visit: www.ompharma.com