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Innovation
Consulting

About the job

For a project of insourcing for one of our clients, we are looking for a technical regulatory affairs professional to join us for exiting projects.

About us

Group 10
Responsibilities

  • Preparation and  coordination of the Registration dossier for submission to Health authorities (Answers to questions and submission).
  • Compilation of the documentation of the M3, with potential update of M3
  • Collaboration and follow up of the technical documentation with SME
  • Follow up of the subcontractor
  • Gain regulatory authority approval
  • Provide on-going regulatory advice to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
  • Liaise with external regulatory authorities as required
  • Perform gap analysis between dossier and manufacturer

Group 11
Education

  • Higher degree in Life Science

Group 12
Experience

  • Minimum of 3 years ‘experience, in regulatory affairs for pharmaceutical products

Group 13
Skills

  • Knowledge of French regulation, Knowledge of European Regulations is a plus
  • Master of English and French languages for business continuity
  • Good management skills
  • Ability to work in a fast paced environment
  • Entrepreneurial mindset
  • Change facilitator
  • Good stress management
  • Able to multitask
  • Project Management skills

Regulatory Affairs Specialist

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