Head of Regulatory Affairs

  • Location

    France

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    €85000 - €105000 per annum + Negotiable

  • Contact:

    Carlos Biggemann

  • Contact email:

    Carlos.Biggemann@volt.eu.com

  • Job ref:

    76968-PHARM-CBG_1597077337

  • Published:

    3 maanden geleden

  • Duration:

    Permanent

  • Expiry date:

    2020-09-09

  • Startdate:

    ASAP

This company is looking for a Director of Regulatory Affairs with significant experience in the field of regulatory affairs and medical writing.

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