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In view of our continued global growth and the organizational development that comes with this we need to assure that our regulatory operations stays up to date and further supports the execution of our company strategy. For this reason we are recruiting our new Regulatory Operations Team Lead in Meyrin/Geneva. In this position you take care of our regulatory operations team.

Reporting to the Regulatory Operations Center of Excellence Team Lead your main missions are as follows:

• Manage and mentor the Regulatory Affairs Operations team of OM Pharma 


• Ensure proper management of RA operations in order to maintain existing registrations, as well as obtaining new registrations


• Be the lead for database systems management including regulatory information management, electronic document management, records/data management and publishing 


• Ensure proper alignment and collaboration within Regulatory Affairs Department, act as key-partner between RA sub-functions (i.e. CMC, labelling and zone managers) to ensure appropriate planning and timely preparation of submissions and to business needs for new applications and processes as well as to streamline processes,


• To contribute to the improvement of departmental and cross-functional processes and systems


• Continuous education on international developments relating to operations activities for the product portfolio


• Coordinate Operations activities for the product portfolio, i.e. document management, formatting, publishing, database update and Health Authorities portals submissions,


• Oversee updates and problem solving issues related to RA systems; rollout of new functionality and work processes within the department,


• Maintain knowledge of RA infrastructure requirements and communicate new developments with potential business impact internally, driving and implementing process changes

The ideal candidate will have a degree in Computer Science or Life Science in addition to the following:

• At least 5 years of experience in Regulatory Affairs Operations, at least 2 of these in in a team management function


• Proven understanding of processes and applications used by Regulatory Affairs


• Experience in projects management, especially database project


• Strong affinity for IT projects and experience in the implementation of software from a regulatory perspective


• Fluency in French and English are a must

You are an organized person with an inclusive and mentoring leadership style. With your analytical and solution-oriented work approach you can assure that issues get resolved appropriately and in a timely manner. Being very adaptable you enjoy to use your excellent communication skills to get the best results for the business even in times of change. 

If this sounds like you please do apply to this new position with us at OM Pharma in our headquarter in Meyrin/Geneva.

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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