Assent Consulting utilizes rigorous selection standards to match the right professional to each position. We use extensive interview techniques and conduct thorough background/reference checks in order to identify only the top professionals with the right academic achievement, technical competence and understanding of domestic and international regulatory requirements.
Positions:
- Director/Associate Director, Regulatory Affairs
- Regulatory Affairs Specialist
- Regulatory Affairs Associate
- Director/Manager, Quality Assurance
- Quality Assurance Associate
- Labeling/Promotions Specialist
- Document Coordinator
Capabilities:
- Lead product development strategies
- Design and submit regulatory documents, including IND/NDA/BLA
- Assist with GMP/GCP compliance
- Develop regulatory affairs SOPs
- Negotiate with regulatory agencies
- Review/submit promotional material to FDA
- Submit complaints to FDA
- Review site packages
- Coordinate labeling activities and monitor compliance reports
- Train regulatory staff
- Evaluate registration strategies
For more information, contact us.
Regulatory Affairs
CAREER OPPORTUNITIES
