Senior Manager, Regulatory Affairs CMC

Biopharma Careers; Wilmington (DE); On-site; USD 120,000 - 180,000; Full time

Job summary

Incyte Corporation seeks an experienced Regulatory CMC professional to manage submissions and strategy for development and marketed products, spanning small molecules and biologics from early development to post-approval. The role requires liaising with FDA and global authorities, ensuring compliant, high-quality submissions, and coordinating cross-functional teams.

The position emphasizes involvement in post-approval activities, changes management, and global program support, with domestic

Qualifications

• In-depth knowledge of pharmaceutical drug development and CMC guidelines.
• Experience in regulatory CMC or related development field.
• Experience with global clinical trial and marketing applications.
• Proficiency with eCTD submissions and regulatory documentation workflows.
• Willingness to travel up to 10% domestically.

Responsibilities

• Manage regulatory CMC strategy for small and large molecule programs.
• Coordinate with FDA and global health authorities as needed.
• Ensure CMC submissions meet current regulatory standards and high quality.
• Review CMC data packages and provide regulatory guidance to teams.
• Lead or participate in CMC strategy meetings with stakeholders.
• Oversee post-approval CMC activities and changes.

Skills

Regulatory CMC knowledge

eCTD submissions

FDA/global health authority liaison

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Advanced degree in Regulatory Affairs or related field

Tools

Electronic Document Management System (EDMS)

Job description

Overview A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job 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. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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The 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 [e-mail] if you have any questions or concerns or would like to exercise your rights.