Regulatory Affairs Project Manager
Job Description:
• Evaluate the impact of clinical/regulatory changes on assigned projects as well as Fortrea business operations
• Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval within 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 Fortrea 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 related 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, Vision, Life, STD/LTD
• 401(K)
• Paid time off (PTO) or Flexible time off (FTO)
• Company bonus where applicable
• Evaluate the impact of clinical/regulatory changes on assigned projects as well as Fortrea business operations
• Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval within 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 Fortrea 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 related 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, Vision, Life, STD/LTD
• 401(K)
• Paid time off (PTO) or Flexible time off (FTO)
• Company bonus where applicable