Regulatory Affairs Manager

Reference: VAC000912

Categorie: Regulatory Affairs

Novellas Healthcare is looking for a Regulatory Affairs Manager. Prefered you work on freelance basis (permanent contract is definitely an option).
You will report to the Director Regulatory Affairs.

Description

  • Preparation and follow-up of global CTA and IND submissions, including responses to Authorities and Ethics Committees
  • Execute oversight on CRO regulatory activities with respect to clinical trial authorisations
  • Tracking of and reporting on CTA/IND submission and approval status
  • Maintenance of public study and study results registries such as clinicaltrials.gov and EudraCT
  • Preparation and follow-up of Scientific Advice/Protocol Assistance procedures
  • Preparation and follow-up of Orphan Drug Designation submissions for EMA or FDA
  • Preparation and follow-up of Paediatric Investigation Plan submissions
  • Contribute to development of processes, including preparation of standard operating procedures
  • Follow (changes of) regulatory legislation and guidances globally

Profile

  • Bachelor or Master degree (Medical, Pharmaceutics, Biomedical Sciences) 
  • 5-10 years of relevant experience in (clinical) Research and Development within the pharmaceutical or biopharmaceutical industry
  • Knowledge of regulatory environment for clinical trials in EU, US and other regions
  • Scientific background allowing contribution to regulatory processes and documents on content level 
  • Excellent knowledge of English (spoken/written)
  • Excellent rganizational and planning skills

Offer

Novellas Healthcare offers you a job in a dynamic work environment and a competitive remuneration package according to your experience.

Novellas Healthcare

Novellas Healthcare is a company with over 10 years of experience in people-related services for the healthcare sector. Our goal is to maximize people’s careers in healthcare, and our customer’s human capital. We provide Permanent and Flexible Staffing Solutions, Training & Coaching and Patient Programs.

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