Manager / Senior Manager, Regulatory Affairs CMC

Incyte Corporation; Morges; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Incyte Corporation in Waadt, Morges, seeks a Manager/Senior Manager, Regulatory Affairs, CMC to lead regulatory CMC submissions and strategy for development and marketed products, spanning small molecules and biologics, from early development through late-stage. The role collaborates with internal partners and external health authorities to ensure compliant, high-quality submissions.

The ideal candidate has a science degree, relevant CMC regulatory experience, and a strong ability to navigate

Qualifikationen

• Bachelor's degree required in a relevant field.
• Advanced degrees in scientific, Regulatory Affairs or related fields desirable.
• 1-3 years of regulatory affairs CMC experience for Manager; 4-6 years for Senior Manager.
• Experience with regulatory CMC aspects of large and small molecule drugs is beneficial.
• Familiarity with global clinical trial and marketing applications, eCTD submissions, and electronic document management systems advantageous.
• Strong knowledge of pharmaceutical drug development and CMC regulations governing biologics and small molecules.

Aufgaben

• Participates in outside professional development meetings to apply latest CMC thinking.
• Maintains knowledge of US and international guidance and proposed rules affecting CMC.
• Liaises with internal teams and health authorities; prepares meeting summaries for regulatory archives.
• Supports post-approval activities and provides timely responses to regulatory questions.
• Ensures submissions adhere to current regulatory standards and high quality.
• Reviews CMC data packages to support trials and marketing applications.
• Supports regulatory CMC strategy for small and large molecule programs.
• Ensures compliance with regulatory guidance and internal policies.

Kenntnisse

Regulatory CMC

Regulatory strategy

Clinical development

Cross-functional comms

Ausbildung

Bachelor's degree

Advanced degree desirable

Jobbeschreibung

Overview

The Manager/Senior Manager*, Regulatory Affairs, CMC will primarily be responsible for supporting / 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).

Duties and 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, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
• Participates in meetings with internal and external partners or teams for clinical development programs or collaborations, to communicate regulatory CMC guidance and strategies. Liaises with health authorities as needed (e.g., telephone contacts, submissions). Participates in regulatory CMC-related health authority meetings for assigned projects. Prepares summaries of meetings and contacts for inclusion in the regulatory archives.
• Participates in and supports / manages post-approval global product activities such as, but not limited to, change control, product complaints, marketing application supplements and variations. Works with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
• 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.
• In alignment with RA-CMC leader, supports / manages regulatory CMC strategy and submission aspects for both small and large molecule development programs.
• Ensures regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.

Requirements

• Bachelor's degree in a relevant field is required. Advanced degrees in scientific, Regulatory Affairs, or related pharmaceutical fields are desirable.
• Relevant experience in regulatory affairs CMC or a related pharmaceutical development field. (1-3 years of experience for manager, 4-6 years' for Senior Manager).
• Experience with regulatory CMC aspects of both large and small molecule drugs is beneficial.
• Familiarity with global clinical trial and marketing applications, eCTD submissions, and electronic document management systems is advantageous.
• Good knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products.

*Please Note: We welcome candidates with varying levels of Regulatory Affairs CMC experience across small molecules, biologics, and lifecycle management activities. The final title and level (Manager or Senior Manager) will be determined by the hiring team based on experience, technical expertise, leadership capabilities, and overall alignment with the position requirements.

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.

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