Non-Clinical Regulatory Consultant

Remote

Contracted

Pintail Solutions

Experienced

Job Description

Job Title	Non-Clinical Regulatory Consultant		Position Type	Part Time Contractor
Location	Remote		Travel Required	N/A
External Posting URL
Applications Accepted By
Jason C. Bork [email protected] Or (317) 694-0232 (mobile)		Mail: Jason C. Bork Pintail Solutions 12175 Visionary Way, Suite 1040 Fishers, IN 46038
Job Description
Overview 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. Roles and Responsibilities 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 and Education Requirements Candidates should have a 4-year college degree, at least 5 yrs regulatory experience including pre-IND enabling non-clinical work, dermal TK/PD studies, and experience with testing in minipigs. Candidates should have strong writing skills and always maintain a professional presence. Preferred Skills Candidates need to thrive in a dynamic, service-minded, entrepreneurial environment. Business maturity and effective communication skills are required as the role will engage with key partners and executives. Candidates should desire to be part of a collaborative team of professionals and be interested in continually learning and developing. They should enjoy working with people, organizing information, supporting client success, and helping teams stay aligned. They should be comfortable operating in a healthcare technology environment where accuracy, professionalism, and clear communication matter. Additional Notes Travel is not expected.

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Non-Clinical Regulatory Consultant

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