Job Description

Job Title: Associate Director, Regulatory Affairs CMC

Department: Regulatory Affairs

Report to: Associate Director, Regulatory Affairs CMC

Grade: Associate Director

Manage People or Team: No

  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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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.
We Respect Your Privacy             Learn more at: http://www.incyte.com/privacy-policyThe 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.