Scientific Search
Clinical Trial Regulatory Affairs Specialist
All potential candidates should read through the following details of this job with care before making an application.
Location: Hybrid, Boston Area is preferred, but open to anywhere in the US
Contract to Permanent
Part-Time 10-20 hours per week to start then hours will ramp up to fulltime
We’re looking for a dynamic, passionate Clinical Trial Regulatory Affairs Specialist to join this organization and ensure compliance across all stages of clinical research projects. The ideal candidate embodies a leadership mentality; unafraid of a challenge, ability to identify gaps and offer solutions quickly, and willingness to contribute ideas to enhance departmental success.
Technology/skills Required
Experience: 5 years in clinical research and 3 years in regulatory affairs at a CRO or sponsor, ideally in biotech or pharma, with hands-on involvement in clinical trial processes as well as CRO experience. Knowledge: Deep understanding of clinical trial regs, GCP, ICH, and ethical standards. Skills: Top-notch organizational, communication, and analytical skills. Education: Bachelor’s or Master’s in regulatory affairs, life sciences, or a related field. Desired Certifications: RAPS, GCP, ICH, SAE, RAC, EMA, etc.
Deliverables Expected
Regulatory Compliance – Ensure all clinical trials meet FDA, EMA, and ICH standards. Documentation Management – Prepare, review, and submit regulatory docs like IND & CTA applications. Ethics Committee Coordination – Help with ethics review board submissions and maintain communication during the study. Audit Support – Assist with regulatory audits by providing required documentation to ensure compliance. This role covers all clinical trial phases, from Phase 1 to Phase 4, including observational & interventional studies! \
How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to lisa@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.
#J-18808-Ljbffr
All potential candidates should read through the following details of this job with care before making an application.
Location: Hybrid, Boston Area is preferred, but open to anywhere in the US
Contract to Permanent
Part-Time 10-20 hours per week to start then hours will ramp up to fulltime
We’re looking for a dynamic, passionate Clinical Trial Regulatory Affairs Specialist to join this organization and ensure compliance across all stages of clinical research projects. The ideal candidate embodies a leadership mentality; unafraid of a challenge, ability to identify gaps and offer solutions quickly, and willingness to contribute ideas to enhance departmental success.
Technology/skills Required
Experience: 5 years in clinical research and 3 years in regulatory affairs at a CRO or sponsor, ideally in biotech or pharma, with hands-on involvement in clinical trial processes as well as CRO experience. Knowledge: Deep understanding of clinical trial regs, GCP, ICH, and ethical standards. Skills: Top-notch organizational, communication, and analytical skills. Education: Bachelor’s or Master’s in regulatory affairs, life sciences, or a related field. Desired Certifications: RAPS, GCP, ICH, SAE, RAC, EMA, etc.
Deliverables Expected
Regulatory Compliance – Ensure all clinical trials meet FDA, EMA, and ICH standards. Documentation Management – Prepare, review, and submit regulatory docs like IND & CTA applications. Ethics Committee Coordination – Help with ethics review board submissions and maintain communication during the study. Audit Support – Assist with regulatory audits by providing required documentation to ensure compliance. This role covers all clinical trial phases, from Phase 1 to Phase 4, including observational & interventional studies! \
How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to lisa@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.
#J-18808-Ljbffr