Sr Manager to Associate Director, Global Regulatory Affairs CMC
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.
The Senior Manager/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/Basic job duties)
• Ensures global regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
• In alignment with RA-CMC leader, manages regulatory CMC strategy and submission aspects for both small and large molecule development programs to worldwide regulatory authorities. Large molecule experience is a plus.
• Provides critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications world-wide.
• Ensures regulatory CMC submissions comply with current global regulatory standards, are of high quality, consistent and complete.
• Participates in and 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.
• Participates in meetings with internal and external partners or teams for clinical development programs or collaborations, in order to communicate global regulatory CMC guidance and strategies.
• Liaises with FDA and other 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.
• Liaises with other regulatory and operations staff to ensure appropriate project support is provided.
• Maintains current knowledge of relevant US and international guidances, 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.
• Other responsibilities, as required.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• BA/BS degree is required. Advanced degree (M.S., Ph.D or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field desirable.
• The Senior Manager requires a minimum of 3 years of experience and the Associate Director requires 4 to 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 preferred. Experience with global clinical trial and/or marketing applications, eCTD submissions and electronic document management systems is required.
• In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products is required.
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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Job posted: 2020-07-06