Global Regulatory Strategy Director

Medicines360; San Francisco (CA); Híbrido; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Medicines360 in San Francisco seeks a Director, Regulatory Affairs to lead global regulatory strategies across drugs, devices, and combination products. You will manage submissions, ensure compliance of TMFs/DHFs, mentor the regulatory team, and oversee external partners while coordinating across US, EU, UK, and LMIC markets.

The role requires 10+ years of regulatory experience, leadership in a fast-paced environment, and strong knowledge of ICH, GXP, and FDA guidelines; RAC certification is a

Formación

• Minimum 10 years regulatory experience across drugs/devices
• Experience submitting regulatory applications to US FDA and other stringent authorities
• Ability to lead a cross‑functional regulatory team and external partners
• Strong grasp of ICH guidelines, GXP, and global regulatory landscapes

Responsabilidades

• Develop and execute global regulatory strategies for complex projects
• Lead regulatory submissions and manage documentation (INDs/IDE, NDAs, CE/UKCA, PADERs/PSURs)
• Oversee TMFs, DHFs, and regulatory recordkeeping
• Guide CMC and medical device development programs
• Mentor regulatory personnel and manage cross‑functional teams
• Maintain regulatory intelligence and adapt strategies to changing legislation

Conocimientos

Regulatory leadership

Cross-functional collaboration

Communication skills

Team mentorship

Prioritization under pressure

Travel readiness

Educación

Bachelor’s degree or equivalent

Post-graduate degree preferred

RAC-Drugs and/or RAC-Device certification desirable

Herramientas

Veeva QMS / RIM

Descripción del empleo

Medicines360 in San Francisco seeks a Director, Regulatory Affairs to lead global regulatory strategies across drugs, devices, and combination products. You will manage submissions, ensure compliance of TMFs/DHFs, mentor the regulatory team, and oversee external partners while coordinating across US, EU, UK, and LMIC markets.

The role requires 10+ years of regulatory experience, leadership in a fast-paced environment, and strong knowledge of ICH, GXP, and FDA guidelines; RAC certification is a