Regulatory Manager

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Provide regulatory guidance throughout the clinical development life cycle • Compile, coordinate, and review applications to Regulatory Authorities, including CTA/INDs, annual reports, amendments, scientific advice or regulatory authority meetings, orphan designations, pediatric planning, and marketing applications • Develop and/or review submission documents for Regulatory Authorities and Ethics Committees to ensure regulatory compliance • Represent Global Regulatory Affairs at project team and business development meetings with external and internal customers • Work within project teams and lead regional or global projects when necessary • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership updated • Assist in developing Regulatory Affairs Specialists and other operational staff • Provide input into regulatory strategy and timelines for new study opportunities • Help establish company standards for high-quality submitted information • Participate in corporate quality initiatives across Clinical Solutions business units • Maintain current knowledge of laws, regulations, and guidelines governing drug development and approval • Provide ICH GCP guidance, advice, and training to internal and external clients

🎯 Requirements

• Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline • Computer literacy, including MS Office/Office 365 • Fluent in English • 5+ years of relevant regulatory affairs experience • Informed knowledge of all aspects of the drug development process, including regulatory milestones • Specialized knowledge of regulatory activities for at least one major region, including the EU or US • Experience with submissions to Regulatory Authorities, including INDs/CTAs, amendments, Scientific Advice Procedures, and post-approval submissions • Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy • Knowledge of clinical trial methodology, protocols, and indications being studied • Knowledge and expertise in regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel, including overnight stays • Strong interpersonal skills and ability to contribute to a team environment • Professionalism, punctuality, ability to deliver on commitments, and service orientation • Ability to manage multiple varied tasks in a fast-moving environment and maintain good records • Ability to work and plan independently and in a team environment • Ability to motivate project team members to meet timelines and goals • Flexible attitude toward work assignments and learning • Ability to resolve project-related problems and prioritize workload with limited management support • Focus on continuous improvement and process efficiency • Ability to collect consistently high-quality data • Effective verbal and written communication • Proficiency in formal presentations to colleagues, investigative staff, and clients

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation