Associate Director Global Regulatory Affairs jobs at Incyte in United States, Wilmington
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Job title (1)
United States
State
Wilmington
13 jobs found
25.05.2025
I
Incyte Associate Director Global Regulatory Affairs United States, Delaware, Wilmington
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,...
Develop and maintain revenue long range forecast, margins and sales and marketing expenses. Maintain Specialty Pharmacy and Wholesale customer contracts. Help departments manage the procurement process, including API. Support Accounting...
Development of protocols for clinical studies. Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans. Drafting and review of clinical...
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...
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