Regulatory Affairs Lead

Role summary

Regulatory strategy and submissions

• Lead submission management and cross-functional teams for complex global regulatory applications.
• Provide strategic regulatory input and anticipate health-authority requirements.
• Manage licenses, registrations, labeling, safety reporting, inspections, audits, and post-marketing requirements.
• Act as the primary regulatory contact with key authorities, including SFDA and GHC.

Business partnering and leadership

• Partner with business units and stakeholders to support the country regulatory agenda.
• Align therapy-area managers, local agents, and global stakeholders on regulatory priorities.
• Manage and develop one to two direct reports through objectives, coaching, and growth opportunities.
• Lead or participate in critical projects integrating regulatory needs into systems and processes.

External engagement and governance

• Build relationships with health authorities, industry representatives, and external partners.
• Monitor regulatory, policy, and industry dynamics and advise on potential impacts.
• Support proposals, reports, costing, and budgets for business-development activities.
• Ensure regulatory activities comply with the Code of Ethics, corporate policies, and local legislation.
• Provide input for audits, inspections, recalls, adverse events, and compliance risks.

Essential qualifications

• Higher education in pharmaceuticals, medicine, or biotechnology is required.
• At least nine years of regulatory affairs experience is required.
• At least five years of multinational-environment experience with proven contributions is required.
• Strong local and international regulatory knowledge, project management, collaboration, people management, and business acumen are required.