Location: Delaware
Reports To: Chief Quality Officer (CQO)
Position Overview
The Regulatory Consultant will provide specialized expertise to GMPLI’s Quality team, ensuring all operations, products, and documentation meet FDA, GMP, and global regulatory requirements. Serving in a consulting capacity, this role will support regulatory submissions, compliance strategies, and audit readiness for the production of GMP-grade water, media, and buffer solutions.
Key Responsibilities
- Advise on regulatory compliance for all aspects of manufacturing, quality control, and distribution.
- Support preparation and review of regulatory submissions, change controls, and product documentation.
- Provide expert input during inspections, audits, and responses to regulatory agencies.
- Monitor regulatory updates and communicate potential impacts to internal teams.
- Train staff on relevant regulatory requirements and best practices.
Qualifications
- Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.
- 8+ years of regulatory experience in pharmaceutical, biotech, or healthcare manufacturing.
- In-depth knowledge of FDA, EMA, ICH, and GMP guidelines.
- Proven experience in preparing for and participating in inspections and audits.
- Strong technical writing and communication skills.
Key Competencies
- Regulatory Expertise
- Attention to Detail
- Strategic Compliance Planning
- Training & Mentorship
- Audit Readiness