Regulatory Consulting Services
Pharmaceuticals
Regulatory Affairs
- Regulatory Strategist: Develops strategies for navigating complex regulatory pathways.
- Regulatory Submission Specialist: Prepares and submits regulatory documents for approvals.
- Regulatory Compliance Auditor: Conducts audits to ensure compliance with regulatory standards.
- Regulatory Liaison: Acts as a liaison between the company and regulatory bodies.
Clinical Research
- Clinical Regulatory Affairs Specialist: Ensures clinical trials comply with regulatory requirements.
Quality Systems
- Regulatory Quality Manager: Manages quality systems to ensure regulatory compliance.
- Data Integrity Compliance Specialist: Ensures electronic records and signatures are compliant with 21 CFR Part 11.
Medical Devices
Regulatory Affairs
- Regulatory Affairs Manager: Oversees regulatory submissions and interactions with regulatory agencies.
- FDA Submission Specialist: Prepares and manages submissions to the FDA.
- International Submission Specialist: Handles submissions to international regulatory bodies.
- Regulatory Compliance Specialist: Ensures ongoing compliance with regulatory requirements.
Quality Systems
- Regulatory Quality Engineer: Integrates quality systems with regulatory requirements.
- Regulatory Documentation Specialist: Manages and updates regulatory documentation.
Post-Market Surveillance
- Post-Market Regulatory Compliance Specialist: Ensures compliance with post-market regulatory requirements.
- Audit Readiness Specialist: Prepares for and manages regulatory audits.
Biologics
Regulatory Affairs
- Regulatory Pathway Strategist: Develops strategies for navigating the regulatory landscape for biologics.
- Regulatory Submission Specialist: Prepares and submits regulatory documents for biologic products.
- Regulatory Compliance Trainer: Provides training on regulatory compliance requirements.
- Gap Analysis Specialist: Identifies and remediates compliance gaps.
Clinical Development
- Clinical Regulatory Affairs Specialist: Ensures clinical trials for biologics meet regulatory standards.
Quality Systems
- Biologics Regulatory Quality Manager: Ensures quality management systems comply with regulatory requirements.
- Data Integrity Specialist: Manages data integrity to comply with regulatory standards.
Most Popular Regulatory Job Positions
Pharmaceuticals
- Regulatory Submission Specialist
- Regulatory Compliance Auditor
- Regulatory Strategist
Medical Devices
- Regulatory Affairs Manager
- FDA Submission Specialist
- Regulatory Compliance Specialist
Biologics
- Regulatory Pathway Strategist
- Regulatory Submission Specialist
- Regulatory Compliance Trainer