Regulatory Affairs Specialist

Job Listing No: 9740000

Regulatory Affairs Specialist

Jubilant DraxImage inc. – Kirkland, QC – Prepare, review, analyze and consolidate all relevant pharmaceutical and related technical information required for the registration of the company’s drug products with Regulatory Agencies; Prepare pharmaceutical and technical documentation for new drug submissions to obtain approval for clinical trials, for marketing a product and for updating drug products already on the market; Write the pharmaceutical and related technical portions of comprehensive summaries and product monographs that are included in the drug submission made to regulatory agencies; Prepare computer-based submission summaries; Ensure compliance with government regulations by providing agencies with all necessary pharmaceutical and technical information relating to changes or modifications of the company’s products. Bachelor’s degree in chemistry, pharmacology, biochemistry or related discipline; Minimum 1-3 years pharmaceutical experience, regulatory affairs experience is required; Knowledge of MS-Office … – Permanent – Full-time

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