Associate Director, Global Regulatory Affairs, Regulatory Strategy

Please review the listings below of currently available job openings.Associate Director, Global Regulatory Affairs, Regulatory Strategy Location : Princeton, NJType : Direct HireID : j-794Posted : Feb 6, 2025The RoleOur client is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of its Global Regulatory Affairs organization.In this role, you will work in close collaboration with the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You will act as contact person with FDA and provide regulatory expertise and guidance on US procedural and documentation requirements to the Global Regulatory Team and cross-functional teams to ensure an optimal US regulatory submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing timely and high-quality submissions to the FDA.This is a hybrid position based in our New Jersey office, and can work remotely 40% of the time. You will report to the Global Regulatory Strategy Team Lead.Responsibilities The responsibilities of the role will include, but are not limited to : Act as US regulatory lead and FDA contact person for assigned project(s) and be responsible for the implementation and maintenance of the US regulatory submission strategy.For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings, supplemental BLA submissions, tracking of progress of PMRs and PMCs, etc.Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure optimal regulatory success.Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the assigned project(s).Participate in the development of and assess the appropriateness of submission documentation to support successful IND and (s)BLA submissions.Evaluate various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and ensure that they are implemented, if applicable.In collaboration with Global Regulatory Lead, plan, prepare and lead FDA meetings as relevant.Support global regulatory lead and labeling strategy lead in development of the Company Core Data Sheet and US Prescribing Information.Responsible for maintenance of the IND.Monitor and assess global and US regulatory guidelines and regulations and current regulatory environment / landscape and their impact on the development of our client’s products.Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and working instructions.Requirements A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field.Minimum of 5 years of experience in Regulatory Affairs.A solid understanding and experience in oncology drug development is highly preferred.Strong project management skills.Prior experience interacting with FDA as sponsor contact person.Experience with managing first wave BLA and / or sBLA submissions is highly preferred.Experience in supporting multiple complex submissions, maintenance of regulatory documentation, and other regulatory support activities.Moreover, you meet the following personal requirements : Strong organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.Must have attention to detail and be able to solve problems with minimal supervision.Be able to work independently with an ability to drive projects to successful outcomes.Robust cross-functional teamwork skills and enjoy working in a global environment.Skills in building and maintaining internal and external collaborative relationships to achieve shared goals.Highly motivated and self-driven individual who enjoys being challenged.Able to prioritize your work in a fast-paced and changing environment.Goal-oriented and committed to contributing to the overall success of our client.Additional Job Description Manage multiple complex regulatory submission projects and drive execution of global plan through collaboration with team members and vendors.Track progress of key process components for own area (e.g. dossier submissions) through engagement with responsible cross-functional teams.Propose systemic actions to ensure efficient, effective, and compliant submissions in line with the overall strategy.Drive compliance with regulatory guidelines through prompt communication with relevant teams and conduct periodic review of all documents and dossiers as applicable.Proactively guide cross-functional teams as a subject matter expert to support submission strategy.#J-18808-Ljbffr