Associate Director, Global Regulatory Affairs CMC

Overview

Background

Incyte Corporation is a fast growing biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics, primarily for oncology. Out first commercial product Jakafi is approved in the U.S. for patients with intermediate or high-risk myelofibrosis and for patients with polycythemia vera who have an inadequate response to or are intolerant of hydroxyurea. Incyte has a diverse and growing portfolio of drug candidates, including both small and large molecules. Incyte is headquartered in Wilmington, Delaware, USA and has locations in Europe and Japan. Incyte Biosciences G.K. Japan was started in 2017 by aiming to become a fully integrated affiliate with clinical studies of several products. In 2021, Pemazyre® (pemigatinib) was launched in japan as first Incyte medication in Japan.

We are currently seeking future talent who will be engaged in the profile described in below.

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)

Education

• BA/BS degree is required. Advanced degree (M.S., Ph.D, Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field desirable.

Experience

• 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.

Language Proficiency

• Fluent in Japanese and English, with exceptional verbal and written communication skills.

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