Job Summary (Primary function)
The Senior Manager, Regulatory Affairs, CMC will primarily be responsible for managing regulatory CMC submissions and strategy for Incyte development and marketed products, for biologic/small molecules, from early development through late-stage (phase 3, registration and post-approval). Extensive experience in biologics preferred.
Essential Functions of the Job (Key responsibilities)
• Ensures 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 biologic/\ small molecule development programs.
• Provides critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications.
• Ensures regulatory CMC submissions comply with current regulatory standards, are of high quality, consistent and complete.
• Participates in and manages pre- and post-approval global product activities such as, but not limited to, change control, and 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 regulatory CMC guidance and strategies.
• Support RA-CMC leader by liaising with FDA and other health authorities as needed (e.g. telephone contacts, submissions). Support RA-CMC leader with preparation for regulatory CMC related health authority meetings for assigned projects. Help prepare summaries of meetings and contacts for inclusion in the regulatory archives.
• Maintains current knowledge of relevant US and international guidance, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
Qualifications (Minimal acceptable level of education, work experience, and competencies)
• BA/BS degree is required in a scientific field. Advanced degree (M.S., Ph.D. or Pharm.D.) in biological sciences (biochemistry, biotechnology, or microbiology), regulatory affairs, or related pharmaceutical field preferred.
• A minimum of 3-5 years of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of biologic/large molecule drugs (monoclonal and bispecific antibodies) highly desirable. Additional experience in small molecules is a plus. Experience with global clinical trial and marketing applications, eCTD submissions, electronic document management systems (e.g., Veeva Vault platform), and Starting Point and Microsoft Word Templates.
• In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
