Regulatory Affairs Specialist - Geneva

We are looking for a Regulatory Affairs Specialist based at our headquarters in Geneva. Reporting to the Regulatory Affairs Head – SRAs & Development, and working in close collaboration with cross-functional teams, your mission is to participate in the definition and execute regulatory strategies related to our chemical product(s) in Europe and China.

Your main responsibilities are as follows:

• Maintain compliance of existing marketing authorizations
• Submit regulatory activities (new registrations, renewals, variations etc.) in Europe and China in coordination with other Regulatory Affairs departments
• Liaise with Regulatory Affairs CMC, and other Regulatory Affairs teams to ensure timely execution of regulatory activities according to the RA submission plan
• Provide to RA international team related brand documentation in support of maintenance in their region (i.e. Module 4, 5, addendum to clinical overviews…etc.) 
• Manage regulatory documentation (CTD sections, CCDS…etc.) and ensure the traceability of regulatory history (filing, archiving, database etc.)
• Liaise with subject matter experts from pre-clinical, clinical, safety and medical team in case of question related to scientific CTD sections and/or labelling
• Represent Regulatory Affairs at relevant teams and meetings
• Coordinate the responses to Q&A for product and region under responsibilty 
• Drive designated regulatory projects within deadlines, from regulatory assessment to implementation, to keep up to date with the latest regulatory requirements

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

• Scientific or Medical degree (Master, Pharmacist or PhD), or equivalent educational background
• At least 5 years of experience in Regulatory Affairs, preferentially in Europe
• Good knowledge of European regulations; knowledge of Chinese regulations would be a strong asset
• Full fluency in English with, ideally, good oral skills in French
• Proficiency in MS-Office tools; knowledge of Veeva Systems is a plus

You describe yourself as a flexible, self-driven 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 deal with tight deadlines. You also demonstrate strong communication skills, a good team spirit and intercultural competencies, which allows you to interact efficiently with various stakeholders. 

Are you interested in this opportunity? Apply as soon as possible and join OM Pharma!