Regulatory Affairs Project Manager

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 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