Senior Director, Global Regulatory Affairs

Role Summary

The Senior Director, Global Regulatory Affairs provides regulatory strategic leadership across multiple clinical development programs for rare diseases. This role serves as the Global Regulatory TA Lead, ensuring global regulatory compliance and timely submissions and approvals for activities including IND, NDA, MAA, and lifecycle management. The position collaborates with cross-functional program teams and represents regulatory affairs to Health Authorities.

Responsibilities

• Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
• Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when serving as the Global Regulatory Lead on a project.
• Oversees the preparation of regulatory documentation (meeting requests/briefing books) in support of interactions with Health Authorities and provides guidance to the team.
• Oversees/ 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 appropriate, consistent, and complete responses aligned with global development strategy.
• Provides global regulatory advice through the product life cycle by representing regulatory in the Program Team when acting as Global Regulatory Lead.
• In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA.
• Actively participates in Health Authority meetings.
• Clearly articulates regulatory challenges/risks, identifies potential solutions, and makes recommendations on path forward to Program Teams and Senior Management.
• Maintains working knowledge of regulatory requirements and guidelines and communicates regulatory changes to Program Teams.
• Effectively manages direct report(s) and provides mentorship to junior professionals.

Qualifications

• Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable.
• A minimum of 15 years in the pharmaceutical industry with at least 12 years in Global Regulatory Affairs; experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory.
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience with major regulatory submissions (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities is highly preferred.
• Experience in all phases of development and post-marketing activities is highly preferred.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.
• Outstanding people management skills.
• Outstanding interpersonal and communication skills.
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy for a product is required.
• Demonstrated proficiency in organizational awareness, including cross-functional representation of Regulatory Affairs on global teams.
• Excellent planning and organizational skills and ability to manage multiple projects with tight timelines.
• Supports the SVP, Global Regulatory Affairs as required.

Additional Requirements

• Travel domestically and internationally is required; anticipated travel 10-15% of work time.
• On-site presence at the headquarters is required (minimum 2 days a week).