Job Overview
Location
Remote, United States
Job Type
Full-time
Category
HR & Recruiting
Date Posted
April 14, 2026
Full Job Description
đź“‹ Description
- • The Regulatory Manager provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.
- • Day-to-day responsibilities include compiling, coordinating, and reviewing applications to Regulatory Authorities (e.g., CTA/IND, annual reports, amendments), developing and reviewing submission documents, serving as a representative of Global Regulatory Affairs in project and business development meetings, overseeing Regulatory Affairs Specialists, maintaining project plans and regulatory intelligence tools, and providing ICH GCP guidance and training.
- • Precision Medicine Group is a leader in precision medicine solutions, supporting pharmaceutical and biotechnology companies through clinical development, regulatory affairs, and commercialization services, with a focus on bringing innovative therapies to market.
- • The role offers opportunities to deepen expertise in global regulatory strategy, lead cross-functional projects, mentor junior staff, and contribute to corporate regulatory function excellence while working on diverse clinical programs across therapeutic areas.
🎯 Requirements
- • Bachelor’s degree in a scientific or healthcare discipline, or equivalent experience
- • 5+ years of relevant regulatory affairs experience
- • Specialized knowledge of regulatory activities for at least one major region (EU or US), including submissions to Regulatory Authorities (INDs/CTAs, amendments, scientific advice procedures, post-approval submissions)
🏖️ Benefits
- • Discretionary annual bonus
- • Health insurance
- • Retirement savings benefits
- • Life and disability benefits
- • Parental leave
- • Paid time off for sick leave and vacation
Skills & Technologies
About Precision Medicine Group
Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.
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