Regulatory Consultant

🔥 1 hour ago

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Pintail Solutions

2 - 10 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

💼 Consulting

Healthcare • Biotechnology • Consulting

Pintail Solutions is a life sciences consultancy that partners long-term with pharmaceutical, biotechnology, academic, and research organizations to lead complex clinical, operational, and organizational initiatives from strategy through execution. They embed with client teams for months or years to provide clinical trial leadership, healthcare informatics, chemistry/manufacturing & control (CM&C) support, fractional CXO services, program and portfolio delivery, and organizational change management—emphasizing disciplined delivery, risk management, and candid external insight. Pintail serves pharma, biotech, technology-focused life sciences programs, and higher education, helping clients deliver regulatory filings, scale operations, and improve research/clinical infrastructure.

📋 Description

• 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

🎯 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. • Business maturity and effective communication skills are required as the role will engage with key partners and executives. • Thrive in a dynamic, service-minded, entrepreneurial environment.

🏖️ Benefits

• Travel is not expected.

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