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Regulatory Affairs Project Manager

Remote Worldwide Hiring now

Job Description:

  • Evaluate the impact of clinical/regulatory changes on assigned projects as well as reputed company business operations
  • Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval reputed company project timelines
  • Monitor project schedule and scope to ensure both remain on track
  • Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both reputed company and client requirements
  • Propose and implement improvements to enhance efficiency and quality of the work performed on assigned projects

Requirements:

  • University/college degree (life science preferred) or certification in a reputed company allied health profession (i.e. nursing, medical or laboratory technology)
  • Understanding of governmental regulatory processes and regulations as pertains to drug regulation
  • Detailed knowledge of financial control procedures (i.e. costing systems, time reporting)
  • Working knowledge of project management processes, especially as it relates to clinical development
  • At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development
  • Fluent in local office language and in English, both written and verbal

Benefits:

  • Medical, Dental, reputed company, Life, STD/LTD
  • 401(K)
  • Paid time off (PTO) or Flexible time off (FTO)
  • Company bonus where applicable

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