Executive, Labeling

Role Overview: As a Regulatory Labelling Specialist at Apotex Inc., you will be responsible for performing all labelling update and maintenance activities related to New Product Development Label creation and Product Life Cycle maintenance for products in the Canadian market. Your role will involve interacting with the point of contact for allocated products, coordinating with vendors/affiliates for artwork creation and updates, and maintaining trackers for label submissions to health authorities. Key Responsibilities: - Coordinate and prepare regulatory submissions and strategies for labelling updates. - Prepare and submit supporting documents for labelling submissions in the Canadian market. - Coordinate with the Point of Contact (POC) or Vendor for artwork creation and updates. - Maintain tracking requirements for label updates using tools like RIMS, Tracking sheets, CCR, etc. - Prepare and update labels/Monographs for New Drug Development or Product lifecycle maintenance in the US and Canada market. - Develop and maintain regulatory knowledge of Canadian regulations. - Manage final product submissions, negotiate with regional teams/regulatory authorities, and obtain timely product approvals. - Perform Electronic Submission Gateway (ESG) submissions and maintain acknowledgments. - Author responses and make decisions regarding changes in the labels. - Define the priority of labelling requirements and plan submissions accordingly. - Maintain user-level knowledge of labelling software. - Interact with internal departments when necessary. - Stay updated on new labelling regulations and seek guidance from leaders to enhance knowledge. - Ensure compliance with established regulatory, compliance, and safety requirements. - Work collaboratively as a team member and demonstrate organizational values such as Collaboration, Courage, Perseverance, and Passion. Qualification Required: - Education: M Pharmacy, B Pharmacy, or Equivalent Degree - Knowledge, Skills, and Abilities: - Basic understanding of regulatory requirements for filing labelling submissions in USFDA, Health Canada, or ROW markets. - Good interpersonal communication and writing skills. - Ability to proofread technical documents for dossier preparation. - Attention to detail for checking packaging artwork material and specifications. - Collaboration skills with team members. - Other Techniques: Plant tissue culture, Biochemical assays. - Self-motivated, responsible, and proactive. - Experience: Must have labelling experience in any market - US, Canada, Europe, or ROW. Note: Apotex Inc. is committed to providing a welcoming and accessible work environment where everyone is valued, respected, and supported to succeed. Accommodations for applicants with disabilities are available during the recruitment process. If you require an accommodation for an interview or testing, please inform us in advance.,