Global Regulatory CMC Manager
Found in: beBee S US - 2 weeks ago
- 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
- Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
- These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
- Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
- Responsible for the global regulatory evaluation of CMC change controls with supervision.
- Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
- Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
- Experience in developing CMC regulatory strategy
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Pharmaceutical Contracts Analyst
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Summit, United States Insight Global Full timeInsight Global is looking for a Sr. Contract Analyst to join one of our large pharmaceutical clients in Berkeley Heights, NJ. The Sr. Contract Analyst serves as an integral contributor working cross functionally in the Contract Lifecycle Management team with responsibility for negotiating contract terms, drafting offer letters, executing, and implementing...
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Scientist/Engineer
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Summit, United States Axelon Services Corporation Full timeJob Description: The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive...
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Scientist/Engineer
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Surgical Tech
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Director, Industrial Hygiene, Safety CoE
Found in: beBee S US - 1 week ago
Summit, United States Bristol Myers Squibb Full timeFrom optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.The Director of Industrial Hygiene will be responsible for leading the development and implementation of global industrial hygiene programs and policies across BMS through the Safety CoE. This...
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Sr Quality Assurance Specialist
Found in: Appcast US C2 - 2 days ago
Summit, United States Integrated Resources, Inc ( IRI ) Full timeThe Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and...
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Sr Quality Assurance Specialist
Found in: Appcast Linkedin GBL C2 - 2 days ago
Summit, United States Integrated Resources, Inc ( IRI ) Full timeThe Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and...
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Investigations Specialist
Found in: Appcast Linkedin GBL C2 - 4 days ago
Summit, United States Integrated Resources, Inc ( IRI ) Full timeJob Description: The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive...
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Investigations Specialist
2 days ago
Summit, United States Integrated Resources, Inc ( IRI ) Full timeJob Description: The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive...
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QA Document Control Associate
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Senior Manager, CTO Plant Engineering
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Summit, United States Bristol-Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
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Practice Manager I
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Associate Director, Strategic Pricing
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Summit, United States CSL Seqirus Full timeThe Opportunity: The Associate Director, Strategic Pricing will have a broad range of responsibilities related to revenue management, pricing strategy, and the development of pricing tools. You will have a comprehensive understanding of revenue management, a thorough awareness of diverse pricing strategies, and the ability to develop appropriate tools to...
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Associate Director, Strategic Pricing
Found in: beBee S US - 3 weeks ago
Summit, United States CSL Behring Full timeThe Opportunity:The Associate Director, Strategic Pricing will have a broad range of responsibilities related to revenue management, pricing strategy, and the development of pricing tools.You will have a comprehensive understanding of revenue management, a thorough awareness of diverse pricing strategies, and the ability to develop appropriate tools to...
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Care Manager
4 days ago
Summit, United States VNS Health Full timeOverviewConducts assessments and develops client/member centered plans of care. Provides coordination of services between the varying providers for clients / members with complex psychiatric, substance use, and/or co-morbid medical conditions. Ensures access and linkage to the full array of necessary physical and behavioral health services and other...
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Care Manager
4 days ago
Summit, United States VNS Health Full timeOverview Conducts assessments and develops client/member centered plans of care. Provides coordination of services between the varying providers for clients / members with complex psychiatric, substance use, and/or co-morbid medical conditions. Ensures access and linkage to the full array of necessary physical and behavioral health services and other...
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Stroke Program Manager
Found in: Talent US C2 - 2 weeks ago
Summit, United States Atlantic Health (SP) Full timeDetails Salary: Open Categories: General Nursing Required Education: High School Internal Number: Overview Atlantic Health System is seeking a full-time Stroke Program Manager at Overlook Medical Center. Responsibilities Essential Functions/Responsibilities of Position: Clinical Responsibilities: * Acts as an expert resource clinical...