Lead Executive - Regulatory Labeling

Lead Executive - Labeling

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

 

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.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

Experience Level

Senior Level