Sitero
Healthcare Insurance • Pharmaceuticals • SaaS
Sitero is a next-generation clinical trial solutions provider that accelerates clinical trials, ensures compliance and safety, and enables innovation through advanced technology and world-class services. They offer a wide range of clinical services, including site support and activation, data management, biostatistics, and drug safety. Sitero specializes in eClinical technology, providing end-to-end, technology-enabled services such as electronic data capture, randomization and trial supply management, clinical trial management systems, electronic consent solutions, and payment systems. Their services also include IRB ethical review, biosafety consulting, and pharmacovigilance agreements, ensuring comprehensive support for clinical research organizations.
201 - 500 employees
⚕️ Healthcare Insurance
💊 Pharmaceuticals
☁️ SaaS
Regulatory Consultant
Job not on LinkedIn
September 21
Sitero
Healthcare Insurance • Pharmaceuticals • SaaS
Sitero is a next-generation clinical trial solutions provider that accelerates clinical trials, ensures compliance and safety, and enables innovation through advanced technology and world-class services. They offer a wide range of clinical services, including site support and activation, data management, biostatistics, and drug safety. Sitero specializes in eClinical technology, providing end-to-end, technology-enabled services such as electronic data capture, randomization and trial supply management, clinical trial management systems, electronic consent solutions, and payment systems. Their services also include IRB ethical review, biosafety consulting, and pharmacovigilance agreements, ensuring comprehensive support for clinical research organizations.
201 - 500 employees
⚕️ Healthcare Insurance
💊 Pharmaceuticals
☁️ SaaS
📋 Description
• Develop and implement global and regional regulatory strategies for product development, clinical trials, and market submissions • Prepare, review, and coordinate regulatory submissions (INDs, NDAs, BLAs, CTAs, MAAs, amendments) • Act as primary regulatory point of contact for clients or project teams and collaborate cross-functionally • Monitor global regulatory changes and provide regulatory guidance to ensure compliance • Support or lead preparation of briefing documents and responses for health authority interactions and attend meetings as needed • Conduct regulatory review of protocols, investigator brochures, clinical study reports, and labeling materials • Manage multiple regulatory projects, track timelines, and report progress to stakeholders • Provide regulatory training and mentor junior regulatory staff • Support business development activities (proposals, presentations) and post-marketing lifecycle management
🎯 Requirements
• Bachelors degree in a science related field is required • MBA or higher education preferred • 10 years minimum previous experience with a CRO, Biotech, or Pharmaceutical manufacturer • Proven ability and experience to provide Regulatory Consulting required • Existing knowledge of Portugal regulatory laws and compliance required • Willing to work part-time hours as needed and in shifts when required
🏖️ Benefits
• Sitero proudly offers a competitive hourly compensation rate package for our contracting staff
Apply Now