Genesis Pharma are currently looking for Regulatory Affairs Manager to join one of the leading Pharmaceutical company in the world based in Paris.  Full time positions with fantastic benefits available to all employees from day 1 and high competitive salaries.

 

Missions

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• Manage the preparation, documentation and submission of FDA applications (SPA, NDA, IND, variations ...)

• Manage the preparation, documentation and submission of FDA marketing authorization applications

• Ensure liaising with FDA and the Company headquarters in Paris

• Review of regulatory compliance with regulatory standards

• Provide regulatory guidance to departments and clinical project teams

• Create or implement regulatory compliance procedures

• Communicate internally regulatory information and ensure its correct understanding

• Maintain current knowledge of relevant regulations

 

Profile

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• A PharmD, MD or PhD degree is mandatory

• A master's degree in management or business administration

• A minimum of 5-year experience in regulatory affairs is required

• Must have thorough knowledge and understanding of EMA / FDA regulations in clinical development, manufacturing and marketing

• Must have significant experience in electronic submissions to EMA / FDA via eCTD (Global Submit Tool is a competitive advantage)

• Must have computer literacy to operate standard office software and electronic applications

• Knowledge French language will be appreciated

 

Additional information

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• Permanent position, available immediately

• Based in New Jersey

• Salary & package to define skills and experience

 

 

To apply for this role, find out more about this or other roles, please forward your most up to date CV to Natalie.hough@genesisglobalgroup.eu and a member of the Genesis Pharma team will be in contact as soon as possible.

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TAGS: Regulatory Affairs Manager – Pharmacovigilance – ADR - Pharmaceutical