Onsite Regulatory Affairs Associate – Grant‑Funded, Full‑Time

Heluna Health; San Francisco (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Heluna Health in San Francisco seeks a Regulatory Affairs Associate to support Bridge HIV, a grant-funded research unit affiliated with DPH and UCSF. You will handle regulatory submissions, SOP development, and document control under the Medical Director.

This onsite, full-time role requires collaboration with study sites, regulatory bodies, and staff to ensure strict adherence to guidelines, HIPAA, and ethical standards. Jointly funded, grant-based employment.

Qualifications

• Degree in biological or related field with experience in coordinating clinical trials.
• Experience with IRB applications and regulatory submissions.
• Ability to develop and implement QA measures for research studies.

Responsibilities

• Submit and track IRB applications for studies including renewals and deviations.
• Maintain study documentation, sponsor communications, and archiving records.
• Draft SOPs and ensure version control and dissemination of docs.
• Collaborate with study personnel on protocols, training, and implementation.
• Lead regulatory group meetings and address compliance issues.

Skills

IRB coordination

Quality assurance

Regulatory submissions

Documentation management

Project collaboration

Education

Bachelor in biological or related field

Tools

Word

Excel

PowerPoint

Access

Trello

Job description

Heluna Health in San Francisco seeks a Regulatory Affairs Associate to support Bridge HIV, a grant-funded research unit affiliated with DPH and UCSF. You will handle regulatory submissions, SOP development, and document control under the Medical Director.

This onsite, full-time role requires collaboration with study sites, regulatory bodies, and staff to ensure strict adherence to guidelines, HIPAA, and ethical standards. Jointly funded, grant-based employment.