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Collaborate on CMC, quality processes and regulatory submissions, providing internal and external project alignment. PhD in Analytical Chemistry with 6+ years in CMC analytical development for small molecule Drug Substance and Drug Product.
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You will report directly to a Principal Scientist in the Genomics Innovation Team. This hiring manager develops and evaluates genomics methods for off-target characterization and supports genotoxicity documentation for Health Authority regulatory interactions.
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As part of an ongoing agency wide effort, Stavros offers specialized training to ensure the Skills Trainers Staff members are well supported and regularly updated on the ever-changing MassHealth PCA regulatory systems.
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Serving as a field resource for The Medical Affairs Company (TMAC), the Clinical Trial Liaison (CTL), reporting as Early Clinical Liaison , will represent the Companys Respiratory Clinical Development program.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Expertise in data analysis tools such as SQL, Excel, and data visualization tools (e.g. Tableau, Power BI, etc.
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Coordinate other essential accounting and regulatory activities, including technical accounting, audit, tax, management reporting, treasury operations, company registrations, and insurance. Manage day-to-day accounting operations, including accounts payable, general ledger, payroll, clinical accruals, CMC accruals, etc.
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Act as the primary point of contact for cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and data management. Ensure adherence to clinical trial plans and regulatory guidelines (FDA, EMA, ICH/GCP.
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Stay informed about market trends and regulatory changes that could impact trading operations. Oversee tasks related to corporate actions, currency hedging, short locates, and general trading operations.
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Assists the Program Leader in overseeing psychiatric care, including documentation that would be required for all department agencies and regulatory compliance. The Addiction Treatment Center at Naukeag is a 30-bed residential treatment program for adults with co-occurring disorders located in Petersham, MA.
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This includes ensuring the risk management framework, processes and practices executed comply with internal policy and applicable regulatory requirements and expectations (in particular SEC and FINRA requirements around in scope businesses.
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As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist. Bachelors degree or higher in Science, Engineering, Regulatory Affairs, or a related field.
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Know-how about regulatory and investor reporting compliance requirements for US markets. Exposure working on market leading Alts performance data providers (SS Alpha, Evestment, Bloomberg, Factset, Morningstar Direct etc.
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Stay current with HR technology trends and understand statutory and regulatory requirements affecting HR, Benefits, Recruitment, and Payroll systems. Manage system access and security, perform data audits, and ensure compliance with regulatory requirements.
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Responsible the implementation and execution of Companion Animal Operations and Aquatics (where applicable) through training and coaching partners to include: Animal Care, Aquatics and Companion Animal Maintenance, Ordering, all Regulatory Compliance, CAPI, HAHC, CAPC and Vet Care/Relationships.
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Ensure strong internal controls around the ESG reporting process and compliance with applicable regulatory frameworks. Certification in ESG or sustainability (e.g., LEED, CSR-P, etc.) The ESG Compliance Manager will be responsible for developing, implementing, and executing our companys ESG strategies and initiatives.
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regulatory affairs cmc jobs in Stoughton, MA
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