Director, Regulatory Affairs

Role Summary

The Director, Global Regulatory Affairs is a strategic role responsible for developing, coordinating, and implementing regulatory strategies for drug development programs for innovative biologic and small molecule products as well as marketed products. This position supports the development and lifecycle management of therapies in the Immunology portfolio, including dermatology, gastroenterology, and respiratory areas, and requires knowledge and experience with INDs and NDAs/BLAs. The role contributes to global and/or regional registration strategies to obtain marketing approval and to expand into new indications with approved products.

Responsibilities

• Responsible for ensuring timely development of regulatory strategies through a global regulatory team approach for innovative products.
• As a global or regional lead within a global regulatory team, develops/coordinates/implements regulatory strategy as a member of a multidisciplinary project team.
• Leads strategic regulatory planning, preparation, and execution of meetings with health authorities (e.g., FDA, EMA).
• Point-of-contact for interfacing with health authorities.
• Regularly reports and communicates to management on progress against objectives and plans, including program risk and mitigation strategies.
• Plans and directs projects and provides technical background, leadership, regulatory intelligence, and consultation to cross-functional colleagues and the global regulatory team.
• Lead facilitator for timely submission and approval of regulatory applications and coordinates responses to health authorities to resolve regulatory issues.
• Provides training and mentorship to regulatory staff.

Qualifications

• Education Required: Bachelor’s Degree in scientific field or equivalent combination of education and related work experience
• Education Preferred: PharmD, PhD, or Master’s degree
• Minimum of 8 years of pharmaceutical industry experience, including at least 5 years in regulatory affairs with experience in major submissions (IND/NDA/BLA/CTA/MAA)
• Working knowledge of relevant drug and biologic regulations and guidances applicable to registration and approval
• Excellent communication and organizational skills
• Experience with eCTD

Skills

• Regulatory strategy development and lifecycle management
• Project leadership and cross-functional collaboration
• Regulatory intelligence and health authority interactions
• Regulatory submissions and defense of major filings

Education

• Bachelor’s Degree in a scientific field (required)
• PharmD, PhD, or Master’s degree (preferred)

Additional Requirements

• Domestic and international travel up to 10% (based on project needs)