Manager, Labelling

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.

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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.