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Job Description
Job Summary
Preparation, compilation for Submission to projects to Health Canada.
To submit the Submission Projects via DocuBridge.
To create the BLUE Project for Non-Commercial and Commercial Workflow.
Maintain the RA Tracker and task
Job Responsibilities
- Ensure to preparation of all require forms and documents for submission projects for Health Canda.
- Send it to peer review in within time line and respond to reviewer’s comments.
- Create and update the RIMS record, CCR-QMS, LAMS-BLUE projects.
- Compile all forms and documents and upload in DocuBridge to submission Health Canada.
- Prepared Text Compare Reports for verification of Package Insert.
- Verification of Labels through proof compare tools in BLUE for approval of Labels.
- Effectively communicate and collaborating with team member for achive all outcomes.
- Timely complete all assigned training in training portal.
- Attained training, webinar, meeting which all are arranged by HR team, Department Laed, or Company.
- To communicate and collaborate with GTA Team regarding projcets.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- M Pharmacy, B Pharmacy or Equivalent Degree
- Knowledge, Skills and Abilities
- Basic knowledge and/or understanding of regulatory requirements for filing labeling submissions in USFDA, Health Canada or ROW markets.
- Good interpersonal communication skills
- Demonstrate good writing skills and compilation of submission documents.
- Proofreading ability for reviewing technical documents required for dossier preparation\
- Attention to detail to check packaging artwork material and specificationsCollaborate with team members.
- Self motivated, taking responsibility and taking initiative.
- Experience
- Must have labeling experience in any market - US, Canada, Europe or ROW.