Genesis Pharma are currently recruiting for a Regulatory Affairs Director to join a leading Pharmaceutical company based in Paris. Full time position with fantastic benefits available to all employees from day 1 and high competitive salaries.

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REGULATORY AFFAIRS DIRECTOR 

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The client is conducting a major clinical development program in inflammatory, neurodegenerative diseases and oncology in multiple phase 3 studies around the world.

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Missions

 

• Represent the company with the health authorities

• Supervise the constitution and follow-up of regulatory files

• Participant in writing the registration dossiers

• Participant in drafting responses to regulatory health authorities

• Ensure the management of the regulatory team

• Provide advice and assistance on aspects to advisors

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Profile

 

• Minimum 12 to 15 years’ experience in regulatory affairs including 5 years in team and project management

• Significant experience in submission files and in drafting regulatory responses to health authorities in launching studies in a country

• Significant experience in writing regulatory reports and clinical study documents (protocol, investigator brochure, clinical report)

• Graduate Diploma in Science (Pharm.D or Ph.D.)

• Fluent English

• Strong analytical skills, work capacity, adaptability in a fast-growing environment

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Additional Info

 

• Start date ASAP but willing to wait for right candidate

• Salary to be defined according to profile and experience
   

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In order to apply for this role, please forward your most up to date CV and quote the reference number.

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TAGS: Regulatory Affairs