Job Title: Senior Manager of Regulatory Affairs Job Description Our company is a pharmaceutical organization developing new oncology therapeutics. We are seeking a Senior Manager of Regulatory Affairs to manage a new NDA submission planned for late this year or Q1 of 2025. The role entails taking over the clinical portion of the submission, authoring the IND independently, and leading a cross-functional team from a regulatory perspective. The responsibilities include defining and authoring compliant content for new and existing dossiers, managing tracking systems, and preparing electronic submissions. The primary focus will be on new submissions for new chemical entities (NCE) and products in non-clinical or clinical studies, with a secondary focus on existing marketed products or those obtained through acquisition. The position will facilitate key regulatory projects, manage regulatory deliverables, and provide guidance on regulatory strategy, including non-clinical and clinical protocol review, dossier content definition, submission building, health authority management, and post-approval commitments. The regional focus is North America, specifically the Food and Drug Administration and Health Canada. Hard Skills * Regulatory review of clinical documentation * Authoring and technical review of clinical summaries * Knowledge of FDA requirements for electronic data sets in module 5 * 8-12 years of industry regulatory experience Soft Skills * Ability to lead cross-functional teams * Risk identification and risk-based decision making * Mentoring less experienced staff Job Type This is a contract position with a duration of 6 Month(s). Work Site This is a fully remote position with some requirements to travel to the site in St. Louis for meetings and upcoming deadlines. About Actalent Actalent 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.