Predominately focused on placing and managing EPA, DPR, FDA, Health Canada/International Good Laboratory (GLP) and non-GLP studies. Reviewing efficacy protocols and reports for compliance with applicable regulations and developing testing strategies unique to each client. Role will involve building relationships with clients, laboratories, and regulators by placing and managing testing to achieve desired marketing claims.
RESPONSIBILITIES:
- Place and manage GLP and non-GLP efficacy studies
- Regulatory compliance review of efficacy protocols and reports
- Design antimicrobial test methods
- Negotiate with regulators on behalf of client(s)
- Develop testing strategy unique to each client
- Follow national and international regulatory issues
- Manage relationships with laboratory staff
- Provide external training
- Create/review SOPs and validation documentation
- Perform client/lab audits
- Participate in trade association meetings
- Travel – 0 to 1 overnight trips/month
QUALIFICATIONS
Required:
- BS Technical Degree
- 5+ years in regulatory affairs or equivalent/related experience in FIFRA efficacy testing or related areas
- Experience managing laboratory testing
- Strong leadership skills, excellent written and verbal communication, and attention to detail
- Innovative problem solver, organization and time management skills
- Able to handle sensitive and confidential situations with tact and diplomacy
- Computer skills including Microsoft Suite
- Preferred:
- EPA FIFRA experience
- Previous experience with government regulatory agencies
- Knowledge of: EPA GLPs, EPA/DPR regulations and standards, AOAC and ASTM methods, and Antimicrobial efficacy testing
Mid-level to advanced candidates invited to apply. Salary based on prior relevant experience.
Visit www.srcconsultants.com to learn about this position, YOUR potential team and company!
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Tuition reimbursement
- Vision insurance
Schedule:
Supplemental pay types:
Education:
Experience:
- Laboratory: 3 years (Preferred)
- EPA Regulations: 3 years (Preferred)
Work Location: Remote