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Regulatory Pharmacist
3 months ago
JOB DESCRIPTIONPerforms job functions consistent with the corporate vision and mission statement and core values of the company.Coordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authoritiesPrepares, attests to, and submits regular reports as may be required by the Food and Drug Administration Office.Act as Regulatory liason personnel for BAI and BFAD, including preparation of documents for initial and renewal registration of new and existing products, License to Operate and performs other liason work.Represents the company in transactions with the Food and Drug Administration Office regarding current Good Manufacturing Practices concerns.Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaintsPerforms such other duties and responsibilities related to and/or implied from the above enumeration.