What are the responsibilities and job description for the Regulatory Affairs Quality Manager position at Connect Life Sciences?
**Contract**
**Remote - PST hours**
**Must be eligible to work in the US without restrictions**
**No 3rd Parties**
Qualifications:
- Bachelor's Degree required
- 5 years of Regulatory Affairs Operations or Strategy experience (biotech/pharma)
- Experience with audits and inspections
- Veeva RIM
- Oncology experience preferred
Job Duties:
- Maintain Reference Safety Information (RSI) trackers, including submission dates and health authority approvals.
- Track RFIs to ensure completion within SOP timelines.
- Monitor aggregate report compliance with health authorities and CROs.
- Ensure Regulatory Affairs documents in TMF and Veeva RIM remain current and complete.
- Monitor training compliance through LMS.
- Coordinate updates and maintenance of Regulatory Affairs SOPs.
- Maintain current Regulatory Affairs study contacts with health authorities.
- Monitor and analyze compliance metrics and support leadership reporting.
- Support Quality Event investigations, CAPAs, and deviation management.
- Assist with regulatory impact assessments and implementation planning.
- Support health authority inspections and maintain inspection readiness.
- Author and maintain Regulatory Affairs procedures and standards.
- Partner with Corporate Training to maintain training matrices and requirements.