Senior Director, Global Regulatory Affairs

Role Summary

Senior Director, Global Regulatory Affairs responsible for regulatory strategic leadership on multiple clinical development programs in rare diseases, serving as the Global Regulatory TA Lead and ensuring global regulatory compliance and timely submissions and approvals (IND, NDA, MAA, lifecycle management).

Responsibilities

• Develops and oversees the global regulatory strategy for projects in the assigned Therapeutic Area (TA), in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
• Leads Global Regulatory Project Team meetings when acting as the Global Regulatory Lead on a project.
• Oversees the preparation of regulatory documentation (meeting requests, briefing books) for interactions with Health Authorities and provides guidance to the team.
• Oversees and leads the preparation and critical review of submission documents to ensure regulatory compliance.
• Contributes to and reviews responses to global Health Authority questions to ensure alignment with global development strategy.
• Provides global regulatory advice through the product life cycle by representing the regulatory function in the Program Team as the Global Regulatory Lead.
• Oversees the development of content and format for regulatory submissions and related variations/amendments internationally in the assigned TA, in partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC.
• Actively participates in Health Authority meetings.
• Articulates regulatory challenges/risks, identifies solutions, and makes recommendations to Program Teams and Senior Management.
• Maintains knowledge of regulatory requirements and communicates regulatory changes to Program Teams.
• Manages direct reports and provides mentorship to junior professionals.

Qualifications

• Bachelor‚Äôs or Master‚Äôs degree in biological or life sciences, pharmacy, medicine, or related field; advanced degree desirable.
• Minimum 15 years in the pharmaceutical industry with at least 12 years in Global Regulatory Affairs; experience with US FDA, Health Canada, and EMA required.
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development, and industry practices.
• Experience with major regulatory submissions (NDA/NDS/MAA), Paediatric Investigation Plans (PIP), and Orphan Drug Designation (ODD) activities preferred.
• Experience across all development phases and post-marketing activities preferred.
• Ability to analyze and interpret efficacy and safety data.
• Strong regulatory operational knowledge.
• Outstanding people management, interpersonal, and communication skills.
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy.
• Proven cross-functional collaboration and global team representation for Regulatory Affairs.
• Excellent planning and organizational skills; ability to manage multiple projects with tight timelines.
• Support for the SVP, Global Regulatory Affairs as required.

Skills

• Regulatory strategy development
• Health Authority engagement
• Regulatory submission preparation and review
• Cross-functional leadership
• Life-cycle regulatory management
• Risk assessment and problem solving
• Regulatory operations and project management

Education

• As listed in Qualifications

Additional Requirements

• Willingness to travel domestically and internationally (approx. 10-15% of work time).
• On-site presence at headquarters required (minimum 2 days a week).