Non-Clinical Regulatory Consultant

Pintail Solutions • Fishers, IN

2d • Remote

About The Position

Pintail Solutions is a trusted life science partner improving global health. We work with a variety of clients including nonprofits, biotechs and pharmaceutical companies, and academic institutions. Clients work with Pintail because of our breadth of experience, our ability to deliver outcomes, and our passion for every project we work on. We focus on the greater good of the client and are fearless about informing clients about what they need instead of what they may ask for. We expect everyone in the company to act like an owner and be insatiable about looking for ways to improve. We value excellence, integrity, and collaboration, and we believe we will make a greater difference in our work when we are having fun doing it.

A client is looking for a regulatory consult on the FDA pre-IND feedback they received ~2 yrs ago, the CRO's large animal dermal toxicology and pharmacokinetic study plans, and scientific and regulatory evaluation of the potential toxicity of the lotion excipients.

We are 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; and
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 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.

Requirements

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

Nice To Haves

• Thrive in a dynamic, service-minded, entrepreneurial environment
• Business maturity
• Effective communication skills
• Desire to be part of a collaborative team of professionals
• Interest in continually learning and developing
• Enjoy working with people, organizing information, supporting client success, and helping teams stay aligned
• Comfortable operating in a healthcare technology environment where accuracy, professionalism, and clear communication matter

Responsibilities

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

What This Job Offers

• Job Type: Part-time
• Career Level: Senior