[Hiring] Non-Clinical Regulatory Consultant @Pintail Solutions

Role Description

Pintail Solutions is seeking experienced Regulatory Consultants with dermal TK/PK experience in minipigs. This engagement is expected to start ASAP and last 1-2 months (est. 30-50 hrs of work). The review is expected to include:

• Whether the proposed studies adequately address the FDA feedback;
• Whether the study designs, dose levels, durations, recovery groups, animal numbers, endpoints, and application sites are appropriate;
• Whether any proposed studies or endpoints appear duplicative, unnecessary, or insufficient;
• Whether the irritation, sensitization, systemic exposure, and local-tissue pharmacokinetic strategies are appropriate;
• Whether the excipient package raises any additional nonclinical safety concerns;
• Identification of important gaps or recommended modifications;
• An overall assessment of whether the proposed package is sufficient to support the planned initial clinical study.

This individual will need to be motivated, driven, and have FDA IND-enabling experience. A mature business presence to successfully engage with internal and external business partners is required.

The following roles and responsibilities entail most of what this role may be asked to do but will expand based on the individual’s and organization’s needs.

• Document Review
• Review documents noted above for the purpose of answering documented questions
• Complete independent research and assessment to answer the questions included above
• Communication, Assessment and Write-up
• Develop written summary and gap analysis with prioritized recommendations
• Share perspectives and findings via video meeting
• Revise written document as necessary

Qualifications

• 4-year college degree
• At least 5 years regulatory experience including pre-IND enabling non-clinical work
• Dermal TK/PD studies experience
• Experience with testing in minipigs
• Strong writing skills
• Professional presence

Requirements

• Thrive in a dynamic, service-minded, entrepreneurial environment
• Business maturity and effective communication skills
• Desire to be part of a collaborative team of professionals
• Interest in continually learning and developing
• Enjoy working with people and organizing information
• Support client success and help teams stay aligned
• Comfortable operating in a healthcare technology environment

Benefits

• Travel is not expected