Manager / Senior Manager, Regulatory Affairs CMC

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

Zusammenfassung

Incyte in Switzerland seeks an experienced Manager/Senior Manager, Regulatory Affairs, CMC to lead regulatory CMC submissions and strategy for development and marketed products, from early development through post‑approval.

You will integrate with clinical, quality, and marketing teams, manage global submissions (eCTD) and health authority interactions, and ensure compliance with evolving regulations while mentoring junior staff.

Qualifikationen

• Bachelor's degree in a relevant field; advanced degrees desirable.
• 1-3 years experience for Manager, 4-6 years for Senior Manager in regulatory CMC.
• Experience with regulatory CMC for large and small molecules beneficial.

Aufgaben

• Participates in external meetings to apply latest CMC thinking.
• Maintains knowledge of US and international CMC guidelines and rules.
• Communicates regulatory CMC guidance to internal/external partners; liaises with health authorities as needed.
• Supports post-approval global product activities and provides timely responses to CMC regulatory questions.

Kenntnisse

Regulatory Affairs

CMC

eCTD submissions

Cross-functional leadership

Global health authorities

Ausbildung

Bachelor's degree in a relevant field

Advanced degree in Regulatory Affairs or related pharmaceutical fields

Tools

eCTD software

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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