Regulatory Affairs Operations

  • Ness Ziona

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about this position

Support and coordinate all regulatory activities

Review of relevant regulations and implementation

Understand the science of the product and process to support regulatory decisions

Support writing, preparation and maintenance of regulatory dossiers and other submission documentation according to international guidelines (EU, FDA, ICH)

Interface with other departments to ensure timely availability of submission documents

Prepare timelines for documents preparations towards submissions

Lead the establishment, management, and maintenance of regulatory documentation center to include all documents for the different projects

Revision, preparation and maintenance of regulatory files (administrative documents and technical documentation in format required by local laws, regulations, and standards)

Organizes and maintains reporting schedules for new product application, investigational new product applications, and periodic submissions

Quality check on submission documents and site essential documents

Duties

Requirements

  • M.Sc/B.Scdegree in Life Sciences, Biotechnology or equivalent
  • Work experience- 3-5 years in industry in regulatory unit
  • Experience with submissions and interactions with regulatory agencies
  • Knowledge of biologicals – advantage
  • Project management experience – Knowledge of MS project advantage
  • Ability to assess and prioritize multiple tasks, projects and demands
  • Fluent English and Hebrew
  • Excellent computer skills, including a working knowledge of Microsoft Office applications.
  • Attention to details
  • Excellent organizational skills
  • Excellent interpersonal abilities

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