OverviewJob Summary (Primary function)
This role 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)
- Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
- Maintains current knowledge of relevant US and international guidance's, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
- 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.
- Ensures regulatory CMC submissions comply with current regulatory standards, are of high quality, consistent, and complete. Provides thorough review of the CMC data packages from team representatives to support clinical trial and marketing applications. Collaborates with CMC experts to provide timely responses to CMC regulatory questions from global health authorities. Oversees post-approval global product activities such as change control, product feedback, marketing application supplements, and variations.
- 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.
- Leads or manages regulatory CMC strategy and submission aspects for both small and large molecule development programs.
- Ensures compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products.
- Minimum of relevant 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.
- A degree in a relevant field is required. Advanced degrees in scientific, Regulatory Affairs, or related pharmaceutical fields are desirable, but equivalent experience will also be considered.
- Willingness to travel domestically up to 10% with reasonable accommodations provided for individuals with disabilities.
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.
