Job Description

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

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:

1. The AI Regulatory Affairs Lead needs to provide regulatory strategy and direction to the business regarding implement, and manage AI‑driven solutions that enhance regulatory strategy, operations, labeling, submissions, and compliance.
2. 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.
3. 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.
4. 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 high‑quality, timely, and compliant services aligned with regulatory requirements and internal standards.

Job Responsibilities

AI Strategy & Governance

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.

Regulatory Publishing

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.

Regulatory Project Management

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.

Regulatory Vendor Management

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.

People Leadership

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.

Job Requirements

• 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 Guidance’s 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.