Head of Regulatory Affairs
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Location
France
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Sector:
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Salary:
€85000 - €105000 per annum + Negotiable
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Contact:
Carlos Biggemann
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Contact email:
Carlos.Biggemann@volt.eu.com
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Job ref:
76968-PHARM-CBG_1597077337
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Published:
meer dan 3 jaar geleden
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Duration:
Permanent
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Expiry date:
2020-09-09
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Startdate:
ASAP
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Consultant:
ConsultantDrop
Main tasks
*Represent the company before the health authorities
*Supervise the constitution and follow-up of regulatory files
*Participate in the drafting of registration dossiers
*Participate in the drafting of regulatory responses to health authorities
*Ensure the management of the regulatory team
*Provide advice and assistance on regulatory aspects to the departments concerned
Candidate profile
*Minimum 12-15 year's experience in regulatory affairs, including 5 years in team and project management
*Significant experience in preparing submissions and regulatory responses to local health authorities for the launch of studies in a country
*Significant experience (in a pharmaceutical company) in drafting regulatory responses and clinical study documents (protocol, investigator brochure, clinical report)
*Post-graduate science degree (Pharm.D, or Ph.D.)
*Fluent English essential
*Strong analytical skills, strong working ability, adaptability in a fast-growing environment