Associate Director/ Director Global Regulatory Affairs Labeling jobs at Incyte in United States, Wilmington
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United States
State
Wilmington
15 jobs found
11.07.2025
I
Incyte Associate Director/ Director Global Regulatory Affairs Label... United States, Delaware, Wilmington
Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards. Author new and/or revised CCDS, USPI and...
Collaborate with Executive Director IAI and Global Product Team to refine clinical development and commercialization strategies. Evaluate and advance innovative formulations, combination products, and delivery mechanisms for dermatology. Guide late-stage...
Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents...
Governance and Maintenance of all Templates and Clause Library configured into CLM. Govern and maintain contract templates. Collaborate with Legal Counsel and other relevant functional area stakeholders, as it relates...
Support activities required within process chemistry, pharmaceutical and analytical development to ensure submission readiness of drugs into international markets. Manage the GMP/GDP readiness of new products for international markets. Provide...
Conduct search and evaluation activities to identify pharmaceutical licensing opportunities and strategic collaborations in key therapeutic areas of strategic interest, including immunology and auto-immunity, oncology and dermatology. Lead the assessments...
Development of protocols for clinical studies. Preparation of clinical development plans. Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions. Monitor,...
Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards. Author new and/or revised CCDS, USPI and...
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