Fishers, Indiana, United States · Remote OK
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 jason.bork@pintailsolutions.…
Skills: Regulatory Affairs, Dermal TK/PK, FDA Pre-IND Feedback, Non-clinical Safety Assessment, Minipig Testing
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Review FDA pre-IND feedback and CRO study plans to ensure adequacy of dermal toxicology and pharmacokinetic strategies. Develop written summaries and gap analyses with prioritized recommendations for initial clinical study support.
Requires a 4-year college degree and at least 5 years of regulatory experience focusing on pre-IND non-clinical work and dermal TK/PD studies in minipigs. Candidates must possess strong professional communication skills and a mature business presence.
| 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:
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
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. |
Your trusted life sciences partner. We help deliver your most important projects.
Pintail Solutions is a strategic consultancy with decades of leadership and execution experience. We partner with organizations across the life sciences ecosystem with a focus on pharma, biotech, and academia. Our team delivers deep experience across business strategy, clinical, quality, healthcare informatics, and organizational change. We develop dynamic strategies, solve tough problems, and drive on time and on budget execution. We work alongside clients for months and often years at a time. What we do: • Grow and scale organizations through fractional leadership • Develop business strategy and organizational design • Enable project and portfolio delivery, including clinical trial leadership, healthcare informatics, quality programs, etc. How we work: • Embedded partnerships, not quick fixes • Strategy and execution delivered by one team • Clear, candid insight that reveals what others may not see or say • Relentless focus on delivering client outcomes Since 2015, clients have trusted Pintail to lead high stakes, complex initiatives that advance science, improve care, and strengthen communities.
Offices: 40 Cricket Knoll Lane, Carmel, IN, US
Your trusted life sciences partner. We help deliver your most important projects.
Pintail Solutions is a strategic consultancy with decades of leadership and execution experience. We partner with organizations across the life sciences ecosystem with a focus on pharma, biotech, and academia. Our team delivers deep experience across business strategy, clinical, quality, healthcare informatics, and organizational change. We develop dynamic strategies, solve tough problems, and drive on time and on budget execution. We work alongside clients for months and often years at a time. What we do: • Grow and scale organizations through fractional leadership • Develop business strategy and organizational design • Enable project and portfolio delivery, including clinical trial leadership, healthcare informatics, quality programs, etc. How we work: • Embedded partnerships, not quick fixes • Strategy and execution delivered by one team • Clear, candid insight that reveals what others may not see or say • Relentless focus on delivering client outcomes Since 2015, clients have trusted Pintail to lead high stakes, complex initiatives that advance science, improve care, and strengthen communities.
Offices: 40 Cricket Knoll Lane, Carmel, IN, US
