Regulatory Affairs Specialist

il y a 2 jours


Paris, Île-de-France Thermo Fisher Scientific Temps plein
Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in France. As a key member of our regulatory affairs department, you will be responsible for the preparation, review, and coordination of country submissions in line with our global submission strategy.

About Thermo Fisher Scientific

At Thermo Fisher Scientific, we offer employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

Responsibilities
  • Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications) in alignment with our global submission strategy.
  • Provides local regulatory strategy advice (MoH &/or EC) to internal clients under mentorship.
  • Coordinates project-specific local SIA services and ensures timely completion of projects.
  • Maintains knowledge of and understands PPD SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Requirements
  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
  • Effective oral and written communication skills.
  • Excellent interpersonal skills.
  • Strong attention to detail and quality of documentation.
  • Good negotiation skills.
  • Basic medical/therapeutic area and medical terminology knowledge.
About This Role

This is a full-time position with an estimated annual salary of €60,000 - €80,000 depending on qualifications and experience.

We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.



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