Director Of Regulatory Affairs

Director of Regulatory AffairsThe Director of Regulatory Affairs is tasked with overseeing Nuclear Medicine Regulatory Affairs dossiers and ensuring compliance with regulatory operations activities in the US. This role involves leading new submissions associated with the chemistry of new chemical entities, as well as products in non-clinical or clinical studies. The Director will facilitate the success of key regulatory projects, manage dossiers, and coordinate with health authorities to obtain approvals for product launches.ResponsibilitiesLead project teams in managing key regulatory projects, prioritizing deliverables, strategy, and tracking regulatory processes.Define and author compliant content for new and existing dossiers, ensuring successful submissions.Implement tracking systems for regulatory affairs compliance and operations.Prepare and submit electronic applications for drugs, biologics, and devices.Facilitate concept building, regulatory strategy, non-clinical and clinical protocol reviews.Head Chemistry Manufacturing Controls dossier modules and manage post-approval commitments.Coordinate communication between Global Business Units and Regional Regulatory Affairs staff.Communicate regulatory governmental policy changes to management.Critically review documentation for regulatory submissions and provide necessary revisions.Define Target Product Profiles and build compliant drug and device approvable dossiers.Serve as liaison for third-party service providers in Nuclear Medicine.Maintain compliance database for tracking project deliverables.Essential SkillsFifteen or more years of relevant experience in the Regulatory Affairs pharmaceutical industry.Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.Bachelor of Science in Chemistry, Pharmacy, Biology, or other life sciences.Five or more years of supervisory experience with direct reports.Additional Skills & QualificationsExperience in oncology therapy products and FDA expectations for oncology products.Clinical regulatory experience embedding regulatory strategy into clinical trial design.Stable job history with long-term tenure demonstrating completion of regulatory objectives.Experience writing Target Product Profiles, non-clinical studies, and reviewing clinical protocols.Work EnvironmentThis position operates on a Monday to Friday schedule, from 8 am to 5 pm, with a preference for onsite work four days a week and one day remote. Responsibilities involve physical tasks such as lifting up to 70 pounds, stairs and evacuation ladders, and wearing safety equipment. A willingness to work outside regular hours, including weekends and holidays as needed.Pay and BenefitsThe pay range for this position is $152000.00 - $165000.00/yr.Full time employee benefits packageWorkplace TypeThis is a fully onsite position in Maryland Heights, MO.Application DeadlineThis position is anticipated to close on Aug 17, 2025.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actALENTaccommodation@actalentservices.com for other accommodation options.