DirecciónIf you have extensive experience with Clinical Trial submissions for Health Canada, English speaker (nice to have French-speaking and written skills) enjoy client interaction, and love working from home, we’d love to connect regarding a home-based Regulatory Affairs Consultant that is currently available on Parexel’s Regulatory Affairs Team!
Experience with Canadian Regulatory Authority, Health Canada (HC).
Initial submissions, maintenance, and closure (iCTA, CTA-A, CTA-N) : Preparation of Regulatory Authority submissions on local level based on local requirements, as requested.
Plan, review and coordinate Regulatory Authority submissions. Collection of country specific Regulatory Authority application requirements and documentation.
Development of regulatory submission plan
Knowledge of the electronic CTA submission to the following Health Canada departments : Pharmaceutical Drugs Directorate (PDD) (previously known as the Therapeutic Products Directorate (TPD)), the Biological and Radiopharmaceutical Drugs Directorate (BRDD) (previously known as the Therapeutic Products Directorate (BGTP)), and the Natural and Non-prescription Health Products Directorate (NNHPD).
Compiling documents from Module 1-3 of the Canadian Clinical Trial dossier to include experience with the Quality of Summary form, IMPD, Clinical trial site information, Labels, etc.
Reviewing labels in English (past label review experience in French is a plus).
Completing the HC 3011 Application Form.
Requesting and / or participating in Pre-submission meetings.
Skills
Project management knowledge.
Client-focused approach to work.
Results orientation.
Teamwork and collaboration skills.
Consulting skills.
Excellent interpersonal and intercultural communication skills, both written and verbal.
Critical thinking and problem-solving skills.
Very good oral and written English.
Good oral and written French (not mandatory).
3-4 years of experience submitting clinical trials in Canada.
Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred.
LI-REMOTE
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