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Regulatory Compliance Specialist The candidate will communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review. Will schedule with and escort state inspectors during inspections and provide post-inspection follow-up information as requested. Analyze regulatory deficiencies or complaints and make recommendations regarding their correction. Coordinate, prepare, or review regulatory submissions for firm and other regulatory entities in states where the company operates, as needed. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures, including communication with General Counsel and Assistant General Counsel. Assist with technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Assist with review of product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. Advise project teams on subjects such as pre-market/pre-inspection/pre-license regulatory requirements, export and labeling requirements, or other regulatory compliance issues. Compile and maintain regulatory documentation databases or systems. Coordinate efforts associated with the preparation of regulatory documents or submissions. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed changes in collaboration with the Legal Department. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Obtain and distribute updated information regarding regulations, laws, guidelines, or standards. Prepare or assist with the preparation of additional information or responses as requested by regulatory agencies. Prepare or maintain technical files as necessary to obtain and sustain license approval. Recommend changes to company procedures in response to changes in regulations or standards. Review and revise protocols to ensure collection of data needed for regulatory submissions. Write or update standard operating procedures, work instructions, or policies. Research and fulfill various legal administrative duties as assigned. Participate in ongoing education and professional development opportunities. Work collectively and respectfully with other team members. Additional duties as assigned by management. Should have prior experience in a regulatory compliance position and familiarity with firm. Experience in the cannabis industry is a plus. Prior experience in a paralegal or legal administrative position is preferred. Should preferably have Bachelor’s degree. Minimum High School or G.E.D equivalent is required.
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