A growing specialty biotech in New Jersey has tasked Junto HLS with recruiting a Regulatory Affairs & Quality Assurance Manager.
- Reviews CMC, Protocols, IBs, and other regulatory/clinical/non-clinical/manufacturing documents and provides input to the appropriate functional team.
- Ensures that all regulatory submissions are assembled and formatted according to ICH/regional regulatory requirements and submits documents electronically to FDA via eGateway.
- Requests functional area development information for Annual Regulatory reporting requirements;
- Assembles and submits to Regulatory Agencies within the required timeframes.
- Reports and tracks all necessary regulatory communications related to ongoing clinical studies and pharmaceutical development. Including clinical adverse events and agreements with regulatory agencies with respect to pharmaceutical development plans.
- Maintain and help ensure Electronic Document Management System is complete with all Registration required documentation from Non-clinical, Clinical and CMC for future project related NDA and Marketing authorizations.
- Ensures all internal quality documents (SOPs, Training etc.) are in place and reviewed by functional department periodically for accuracy.
- Serves as host for regulatory and quality operations; advises/assists site operations during regulatory and third party inspections.
- As necessary, performs internal and vendor audits against GXP requirements, company policies & procedures, and contractual agreements; communicates observations to senior management via reports.
- Documents any critical problems pertaining to the external and internal audits. Tracks and trends audit observations and CAPAs.
- Interprets regulations and maintains an awareness of industry trends on compliance issues.
- Manages all regulatory and quality documents and ensures compliance with record retention schedule.
- Northern NJ
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.