Senior Manager, Regulatory Affairs CMC

Incyte; Wilmington (DE); On-site; USD 130,000 - 210,000; Full time

Job summary

Incyte is seeking a Regulatory CMC professional to manage submissions and strategy for its development and marketed products, spanning small molecules and biologics from early development through post-approval. The role requires coordinating with global authorities and cross-functional teams to ensure high-quality, compliant CMC documentation.

You will stay current with evolving FDA and international guidance, lead or participate in regulatory CMC meetings, and oversee post-approval activities

Qualifications

• In-depth knowledge of pharmaceutical drug development and CMC regulations governing development of pharmaceuticals/biotech products.
• Experience with regulatory CMC aspects of both large and small molecule drugs.
• Experience with global clinical trial and marketing applications, eCTD submissions, and electronic document management systems.

Responsibilities

• Participates in external meetings to apply the latest thinking to CMC strategies.
• Liaises with FDA and global health authorities; leads or participates in CMC-related meetings and prepares summaries for archives.
• Ensures CMC submissions meet regulatory standards and supports responses to inquiries from authorities.
• Leads regulatory CMC strategy and submission activities for small and large molecule programs.

Skills

Regulatory CMC knowledge

Pharmaceutical development

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Advanced degree in Regulatory Affairs or related field

Tools

eCTD systems

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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Learn more at: http://www.incyte.com/privacy-policy

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.

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