Hiring: Regulatory Manager Company: Precision Medicine Group Location: Gladstone, NJ Job Posted Time: 2026-09-10 14:13:48 Target Skills & Keywords : GCP, Microsoft Office About the job Required Skills: •Provides regulatory guidance throughout the clinical development life cycle •Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required. •Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards •Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers •Works within a project team, and where necessary, leads project for the region or globally •Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs •Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. •Assist in development of Regulatory Affairs Specialists and other operational area staff, as required Qualifications: •Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline •Computer literacy (MS Office/ Office 365) •Possesses basic understanding of financial management •5 + years or more relevant regulatory affairs experience •Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones •Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions •Demonstrated capacity to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy •Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied •Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development •Availability for domestic and international travel including overnight stays Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!