Manager Global Regulatory Scientist, Regulatory Affairs

Overview

As Manager Global Regulatory Scientist, you will steer global regulatory submissions and strategies to bring innovative medicines to patients. You work within Regulatory Affairs to coordinate multi-country filings and interactions with health authorities. You will drive plan quality, timelines, and cross-functional collaboration to support NDA/MAA submissions and lifecycle management. This role blends scientific rigor with regulatory leadership to advance transformative therapies at a global scale.

Responsibilities

• Draft cover letters and support preparation of applications (IND, CTA, MAA/NDA, eCTD) for regulatory submissions
• Ensure regulatory alignment for CTA/IND protocols and advise on required documents and submission strategies
• Provide regulatory support throughout NDA/MAA registration processes and advise on documents and timelines
• Assist with NDA/MAA availability, track critical path and ensure timely component readiness
• Coordinate submission packages for LOCs and prepare meetings with Regulatory Agencies
• Develop responses to HA queries and ensure high-quality, timely replies
• Liaise with LOCs and monitor submission/response dates; act as back-up on cross-discipline teams
• Organize and lead meetings as needed; support inspections, audits, and adverse events
• Contribute to global regulatory team discussions and strategic planning; research regulatory requirements
• Support regulatory process improvements and cross-functional project management
• Advise on regulatory strategies and disease-area considerations; participate in global health authority interactions

Key requirements

• Bachelor’s degree in scientific or equivalent discipline; advanced degree preferred
• 6+ years of health-regulated industry experience (or 5+ years with Master’s) or 4+ years with PhD/PharmD
• At least 4 years regulatory affairs experience in pharmaceutical/biotech industry
• Experience with IND/CTA, NDA/MAA submissions and life-cycle management
• Knowledge of FDA and ICH regulations and guidelines; familiarity with global HA processes
• Experience with health authority interactions and strategic regulatory planning
• Ability to work across pharma, devices, and combo products
• Strong leadership, organization, and cross-functional collaboration skills

• Strong organizational and time management
• Effective collaboration and communication
• Conflict resolution and leadership in matrix environments
• Regulatory submissions (IND/CTA/NDA/MAA) and eCTD
• HA interactions and inspection readiness
• Life cycle management and regulatory strategy

…