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Lead discussions with cross functional partners and provide guidance to business teams and product development on appropriate regulatory compliance and labeling for Over-the-Counter drugs, Natural Health Products and Dietary Supplements.
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Certified Anti-Money Laundering Specialists (CAMS), Certified Internal Auditor (CIA), Certified Information Systems Analyst (CISA), Certified Regulatory Compliance Manager (CRCM) or other relevant professional certification.
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Experience in other areas of regulatory reporting including 15c3-3 Customer Reserve, CFTC segregation requirements, and the Possession or Control Requirements of SEC Rule 15c3-3. Experience and expertise in SEC/FINRA Broker Dealer Regulatory Reporting, including performing the 15c3-1 Net Capital and FOCUS reporting process.
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Execute various controls and procedures to ensure accuracy, completeness, and compliance with regulatory standards, while continuously monitoring and refining processes to mitigate risks and improve efficiency within the regulatory reporting framework.
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Experience reviewing regulatory documents, DMPK and BA reports, and non-GLP/GLP data and notebooks. " Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
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Experience and expertise in SEC/FINRA Broker Dealer Regulatory Reporting, including performing and/or overseeing the 15c3-1 Net Capital and FOCUS reporting process. Will require strong leadership abilities to oversee complex regulatory reporting processes requiring daily stakeholder management across Operations, Finance, Risk, Treasury, Compliance and Legal.
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Regulatory drug development experience of >5 years. Leading pharmaceutical company looking for a Nonclinical Regulatory and Scientific Writer. Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents.
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Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines. Immediate need for a talented Regulatory Document and Scientific Writer.
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Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
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Fixed income compliance experience is required, and exposure to derivatives, mortgage loans, real estate, private placement, hedge fund, private equity is a plus. Our Global Legal, Compliance and Regulatory (GLCR) team provides first class advice to colleagues and functions across the organization – ensuring AIG navigates an ever-changing landscape that spans state, federal, and international lines.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Our client is seeking a Nonclinical Regulatory Document and Scientific Writer in Summit, NJ. Assist with quality review of DMPK reports that are generated by DMPK scientists by fully reviewing the raw data outputs/electronic notebooks and ensuring validity and quality of reported data in the reports, in addition to reviewing DMPK regulatory documents, editing of nonclinical study reports for regulatory acceptance and adherence to company templates, SOPs, DMPK/BA methods, work practices and FDA GLPs, as applicable.
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Ensure that all activities and duties are carried out in full compliance with regulatory requirements, Enterprise Wide Risk Management Framework and internal Barclays Policies and Policy Standards.
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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
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Partner with business acting as a liaison to bridge US Government Compliance and regulatory requirements with foreign country specific laws and regulations. 2 + years of experience with FAR, CAS and U.S. Government Compliance.
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guest experience regulatory compliance jobs Company: Petco in East Hanover, NJ
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