at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Associate Director, Regulatory Affairs CMC will primarily be responsible for 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).
Essential Functions of the Job (Key responsibilities)
Ensures compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.
Leads or manages regulatory CMC strategy and submission aspects for both small and large molecule development programs.
Leads or participates in meetings with internal and external stakeholders/business partners or teams for clinical development programs, in order to communicate regulatory CMC guidance and strategies.
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. Works with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
Manages post-approval global product activities such as, but not limited to, change control, product complaints, marketing application supplements and variations.
Liaises with FDA and other global health authorities as needed (e.g. telephone contacts, submissions). Leads or participates in regulatory CMC related health authority meetings for assigned projects. Prepare summaries of meetings and contacts for inclusion in the regulatory archives.
Maintains current knowledge of relevant US and international guidance's, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BA/BS degree is required. Advanced degree (M.S., Ph.D, Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field desirable.
Minimum of 4-8 years of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of both large and small molecule drugs desirable. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems.
In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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