Remote Senior Regulatory Specialist - IVD FDA Submissions

Planet Pharma; California (MO); Remote; USD 68,880 - 92,299; Full time

Job summary

A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical Science and expertise in regulatory affairs, particularly in IVD product development. The specialist will collaborate with R&D teams, shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific writing and communication skills are essential. Enjoy competitive compensation and flexible work arrangements.

Qualifications

• Strong scientific writing skills with a track record of peer-reviewed publications.
• Hands-on molecular biology lab experience (e.g., PCR/qPCR, NGS library preparation).
• Regulatory Affairs experience in IVD and involvement in at least one FDA submission package.

Responsibilities

• Partner with R&D to shape analytical validation study designs and author protocols.
• Ensure study designs align with IVD regulatory expectations.
• Author and maintain high-quality analytical sections for FDA submissions.

Skills

Scientific writing

Molecular biology lab experience

Regulatory Affairs experience

Cross-functional communication

Education

Ph.D. in Biomedical Science

Job description

A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical Science and expertise in regulatory affairs, particularly in IVD product development. The specialist will collaborate with R&D teams, shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific writing and communication skills are essential. Enjoy competitive compensation and flexible work arrangements.