Regulatory Affairs, Senior Associate
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Description
The responsibilities will be to:
To plan, organize, file regulatory submissions (e.g., NDS, NDA, SNDS, DINA, NC, CTA, IND) and reports with agencies (e.g., Health Canada, FDA ) . Prepare submissions for changes to approved products for regulatory agencies as per required regulatory timelines.
Monitor and ensure compliance with federal regulations, analyse, interpret and implement international regulations. Maintain and classify documents and guidelines - Review product labelling , submit and update product monographs.
Liaise with internal QA/QC department, laboratories and suppliers. Develop and implement SOPs
Specific knowledge
Qualifications:
Bachelor Degree sciences or chemistry - 5 to 10 years of experience in regulatory affairs submission Be familiar with TPD/FDA/ICH guidelines.
Good communication skills, documentation, organisation. Bilingual (French/English) - Proficient Microsoft Office.