Manager, Labelling
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Job Summary
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.
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In this role the manager needs to provide regulatory strategy and direction to the business regarding healthcare industry regulatory by working closely with US FDA and Health Canada.
- Leads and manages a team of Regulatory Affairs based in India for the following:
- The AI Regulatory Affairs Lead needs to provide regulatory strategy and direction to the business regarding implement and manage AIdriven solutions that enhance regulatory strategy operations labeling submissions and compliance.
- The Project Management Regulatory Affairs Lead is responsible for planning coordinating and driving regulatory activities required to support product submissions approvals lifecycle management and compliance.
- The Publishing Regulatory Affairsl Lead is responsible for leading a team that validates and publishes global regulatory submissions in compliance with eCTD and regional regulatory standards.
- Regulatory Affairs Lead is responsible for overseeing evaluating and managing external vendors who support regulatory and pharmacovigilance activities. This role ensures that all vendors deliver highquality timely and compliant services aligned with regulatory requirements and internal standards.
Develop and execute the AI roadmap for Regulatory Affairs ensuring alignment with global regulatory requirements and business objectives. Partner with Regulatory Global Labeling and CMC teams to identify AI opportunities that enhance efficiency compliance and decision-making. Guide users on the effective and responsible use of AI tools including Copilot and deliver training programs to support adoption. Monitor regulatory trends competitor activities and evolving guidelines to provide strategic insights. Drive change management initiatives and promote continuous improvement through AI-enabled solutions.
Lead and develop a team of regulatory publishing specialists overseeing resource planning workload management training and performance. Ensure regulatory submissions comply with eCTD standards ICH guidelines and regional health authority requirements. Maintain publishing SOPs templates and processes while driving implementation of new technologies and best practices. Collaborate with stakeholders IT teams and vendors to ensure system reliability timely submissions and effective issue resolution. Identify and mitigate risks to ensure on-time delivery of high-quality submissions.
Develop and manage regulatory project plans timelines and submission schedules. Coordinate cross-functional teams across Regulatory Labeling and CMC functions to ensure alignment on scope milestones and deliverables. Proactively identify risks dependencies and issues implementing mitigation plans to maintain timelines. Support continuous improvement initiatives that strengthen regulatory processes documentation practices operational efficiency compliance and data quality. Promote adoption of AI tools and innovative ways of working to enhance project execution.
Serve as the primary contact for regulatory and pharmacovigilance vendors ensuring compliance with GxP data privacy and global regulatory requirements. Manage vendor performance audits CAPAs contracts renewals and service agreements while identifying opportunities for cost optimization and process improvement. Partner with Procurement Legal Quality Clinical Supply Chain and IT teams to support vendor governance issue resolution and successful implementation of new systems or services.
Lead coach and develop employees through regular performance discussions goal setting mentoring and career development. Foster a culture of trust collaboration innovation accountability and continuous improvement aligned with company values. Support talent acquisition onboarding employee engagement and compliance with company policies and procedures while ensuring a safe and high-performing work environment.
- Education
- A Graduate/ Postgraduate in pharmacy
- Knowledge Skills and Abilities
- Excellent analytical and problem-solving skills
- Excellent oral/written communication in English
- Knowledge of recent updated Guidances of Health agencies
- Excellent organizational & interpersonal skills; experience in working in a dynamic team environment
- Advanced knowledge of Microsoft Office: Excel PowerPoint Word
- Basic knowledge of AI
- Experience
- At least 15 years pharmaceutical industry
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.
Required Experience:
Manager
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
