Senior Regulatory Specialist
2 weeks ago
Job Summary Responsibilities Fresenius Kabi USA, LLC seeks Senior Regulatory Specialist to perform the following duties: Represent Regulatory Affairs ("RA") on project teams and provide regulatory guidance. Review technical documents for cGMP and regulatory compliance. Train and coach others in regulatory requirements. Prepare and file high-quality submissions to regulatory authorities, including abbreviated new drug applications ("A/NDA's"), Supplements, Amendments, Annual Reports and drug mater file ("DMF") updates. Communicate the importance of quality assurance and develop quality standards for RA. Provide regulatory decisions with regard to acceptability of submission documents and decisions. Develop and brainstorm regulatory strategies and options for resolving complex and difficult issues that could result in project termination if not addressed. File all applications in accordance with predetermined timelines. Represent the company before regulatory agencies and industry groups. Use persuasive communication to influence regulatory agencies. Train new regulatory scientists on RA and internal systems. Mentor regulatory scientists regarding regulations, and provide comments and perspective on proposed regulations. Requirements: Must have a Bachelor's degree in a scientific discipline and 48 months of experience in Regulatory Affairs Specialist or related occupation in pharmaceutical regulatory affairs or related role supporting regulatory submissions & FDA deficiency responses. Must also possess the following (quantitative experience requirements not applicable to this section): demonstrated experience preparing and filing complete A/NDAs, supplements, amendments and annual reports to the FDA. Demonstrated experience working with CFR and FD/ICH guidelines and cGMPs as pertaining to pharmaceuticals. Salary $103,241.25 to $133,442.00 per year Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status. Minimum Salary: 31200.00 Maximum Salary: 31200.00 Salary Unit: Yearly
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Regulatory Specialist
4 weeks ago
buffalo, United States Tech Mahindra Full timeRole: BA/ Regulatory reporting and data governance specialistLocation: Buffalo, NYThe role will be part of a broader team aimed at Enterprise Risk Management for the client. As part of job responsibilities, will work on initiatives of credit, market, operational risk and data quality improvement initiatives, should be aware of the latest trends in this...
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Regulatory Specialist
1 month ago
Buffalo, United States Tech Mahindra Full timeRole: BA/ Regulatory reporting and data governance specialistLocation: Buffalo, NYThe role will be part of a broader team aimed at Enterprise Risk Management for the client. As part of job responsibilities, will work on initiatives of credit, market, operational risk and data quality improvement initiatives, should be aware of the latest trends in this...
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Regulatory Specialist
1 month ago
buffalo, United States Tech Mahindra Full timeRole: BA/ Regulatory reporting and data governance specialistLocation: Buffalo, NYThe role will be part of a broader team aimed at Enterprise Risk Management for the client. As part of job responsibilities, will work on initiatives of credit, market, operational risk and data quality improvement initiatives, should be aware of the latest trends in this...
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Buffalo, United States Tech Mahindra Business Process Services Full timeRole: BA/ Regulatory reporting and data governance specialistLocation: Tamp, FL/Buffalo NYThe role will be part of a broader team aimed at Enterprise Risk Management for the client. As part of job responsibilities, will work on initiatives of credit, market, operational risk and data quality improvement initiatives, should be aware of the latest trends in...
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buffalo, United States Tech Mahindra Business Process Services Full timeRole: BA/ Regulatory reporting and data governance specialistLocation: Tamp, FL/Buffalo NYThe role will be part of a broader team aimed at Enterprise Risk Management for the client. As part of job responsibilities, will work on initiatives of credit, market, operational risk and data quality improvement initiatives, should be aware of the latest trends in...
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Senior Care Specialist
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Senior Organizational Development Specialist
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Skilled Medication Care Specialist
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Senior Corporate Legal Specialist
2 weeks ago
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Senior Security Systems Specialist
2 weeks ago
Buffalo, New York, United States Johnson Controls Full timeJob OverviewWe are seeking an experienced Senior Security Systems Specialist to join our team at Johnson Controls.About the RoleThis is a senior-level position responsible for the installation, commissioning, and service of large-scale security systems including access control, CCTV, intrusion alarms, and IP intercoms.Key ResponsibilitiesOversight of...
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Senior Infrastructure Automation Specialist
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Senior Dermatology Healthcare Specialist
2 weeks ago
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Senior Mechanical Systems Design Specialist
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