Manager / Senior Manager, Regulatory Affairs CMC

Overview The Manager/Senior Manager*, Regulatory Affairs, CMC will primarily be responsible for supporting / managing regulatory CMC submissions and strategy for Incyte development and marketed products, including both small molecules and biologics, from early development through late-stage (phase 3, registration and post-approval). Duties and Responsibilities Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies. Maintains current knowledge of relevant US and international guidance, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development. Participates in meetings with internal and external partners or teams for clinical development programs or collaborations, to communicate regulatory CMC guidance and strategies. Liaises with health authorities as needed (e.g., telephone contacts, submissions). Participates in regulatory CMC-related health authority meetings for assigned projects. Prepares summaries of meetings and contacts for inclusion in the regulatory archives. Participates in and supports / manages post-approval global product activities such as, but not limited to, change control, product complaints, marketing application supplements and variations. Works with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities. Ensures regulatory CMC submissions comply with current regulatory standards, are of high quality, consistent and complete. Provides critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications. In alignment with RA-CMC leader, supports / manages regulatory CMC strategy and submission aspects for both small and large molecule development programs. Ensures regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained. Requirements Bachelor's degree in a relevant field is required. Advanced degrees in scientific, Regulatory Affairs, or related pharmaceutical fields are desirable. Relevant experience in regulatory affairs CMC or a related pharmaceutical development field. (1-3 years of experience for manager, 4-6 years' for Senior Manager). Experience with regulatory CMC aspects of both large and small molecule drugs is beneficial. Familiarity with global clinical trial and marketing applications, eCTD submissions, and electronic document management systems is advantageous. Good knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products. *Please Note: We welcome candidates with varying levels of Regulatory Affairs CMC experience across small molecules, biologics, and lifecycle management activities. The final title and level (Manager or Senior Manager) will be determined by the hiring team based on experience, technical expertise, leadership capabilities, and overall alignment with the position requirements. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. We Respect Your Privacy Learn more at: http://www.incyte.com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights. #LI-IC1

Biopharmaceutical company discovering and developing small molecule drugs in oncology and inflammation. Headquartered in Wilmington, DE.

incyte.com