Regulatory Affairs Project Manager
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Job Description
Project Manager overseeing regulatory affairs in the pharmaceutical industry at Fortrea. Managing budgets and ensuring compliance with regulatory guidelines in a remote US position.
Responsibilities:
- 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
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