Regulatory Affairs Manager Abbott Laboratories

Abbott is seeking an experienced Regional Regulatory Affairs Manager to lead regulatory strategy, market access, and pricing activities across a multi country cluster. This role works closely with regional teams, government authorities, and industry stakeholders to enable successful product launches, lifecycle management, and sustainable business growth.

Regulatory Strategy & Business Support

• Define and implement short , medium , and long term regulatory strategies aligned with business objectives
• Provide strategic regulatory guidance to internal teams, distributors, health authorities, and industry associations
• Lead product registrations, new indications, line extensions, renewals, and variations
• Monitor healthcare policy, pricing, and reimbursement trends and develop effective response strategies
• Translate regulatory strategy into actionable plans while proactively managing risks and issues

Operational Excellence

• Oversee country Regulatory Affairs teams across the cluster
• Ensure execution of regulatory activities including submissions, labeling, clinical trial support, licenses, and post marketing lifecycle management
• Prepare and deliver regulatory plans that support sales, market share, and profitability goals
• Manage pricing strategies, reference pricing reviews, and authority submissions in collaboration with Finance

Market Intelligence & Business Development

• Partner with Business Development and Marketing on product portfolio expansion
• Provide regulatory input across all stages of product development and lifecycle planning
• Track market, competitor, and market access trends to identify risks and opportunities
• Anticipate regulatory obstacles and develop cross functional solutions

People Leadership

• Lead and develop Regulatory Affairs teams in a matrixed, multicultural environment
• Drive performance management, talent development, succession planning, and coaching
• Foster a high performance culture focused on collaboration, accountability, and growth

Business Partnering & External Engagement

• Build and maintain strong relationships with Ministries of Health, payers, and key stakeholders
• Act as area label coordinator, working closely with QA, manufacturing, and global teams
• Support value proposition development and partnership initiatives

Compliance & Quality

• Ensure compliance with regulatory, quality, and corporate SOPs
• Support continuous improvement initiatives and training compliance
• Champion Abbott s values and ethical standards

Key Success Factors

• Strong influencing, communication, and stakeholder management skills
• Deep understanding of local regulatory and healthcare environments
• Proven ability to translate strategy into execution and results
• Collaborative leadership style with a track record of building high performing teams