[Hiring] Director of Regulatory Affairs @Somewhere

Role Description

We are seeking an experienced Director of Regulatory Affairs to serve as a Global Regulatory Lead across our drug development portfolio. In this role, you will be responsible for designing and executing comprehensive global regulatory strategies, leading cross-functional submission teams, and managing direct interactions with health authorities. The ideal candidate brings deep expertise in regulatory strategy, clinical development, and health authority engagement, along with the agility to thrive in a fast-paced environment.

Qualifications

• Bachelor’s degree in life sciences or a related scientific discipline.
• Minimum of 10 years in biotechnology or pharmaceutical development, with significant focal experience in Regulatory Affairs.
• Demonstrated success leading or supporting global regulatory strategy, health authority interactions, and major submissions for early- to late-stage clinical programs.
• Exceptional scientific/medical writing skills, with a proven ability to distill complex data into clear, persuasive regulatory narratives.
• Proven ability to operate effectively, strategically, and independently within a dynamic clinical development setting.

Requirements

• Advanced Degree: M.S., Ph.D., PharmD, or J.D. in a relevant field.
• EU Regulatory Expertise: Hands-on experience navigating the European Medicines Agency (EMA) processes and the Clinical Trials Information System (CTIS).
• Specialized Modalities: Direct experience with radiopharmaceuticals or specialized therapeutic platforms.

Benefits

• Independent Contractor (100% Remote / Virtual).
• Remote structure requiring self-direction, reliable high-speed connectivity, and the ability to collaborate across global time zones.