Regulatory CMC Director

We are seeking a highly skilled Regulatory CMC Director to join our team at Solid Biosciences.

As a Regulatory CMC Director, you will play a critical role in driving the development and implementation of global regulatory strategies for our gene therapy programs.

• You will collaborate with cross-functional teams to generate and refine product development strategies.
• Lead quality portions of global clinical trial applications, including INDs/CTAs/GMOs and amendments.
• Coordinate and drive regulatory CMC submissions, ensuring timely completion and accuracy.
• Actively contribute to the preparation and execution of global agency meetings.
• Support the development and implementation of global regulatory CMC strategies, identifying regulatory risks and opportunities.
• Monitor regulatory policy and intelligence, disseminating information to inform program strategy.

Requirements:

• Bachelor's degree in a scientific discipline; Masters, PharmD, or PhD preferred.
• Minimum 4 years of experience in regulatory affairs, including IND activity, global CTAs, DSURs, and Agency briefing documents.
• Strong knowledge of US and EU regulations and Guidances pertaining to investigational drug studies.
• Excellent organizational and program management skills, prioritizing tasks to achieve deadlines.
• Excellent communication and collaboration skills, working with multi-disciplinary teams.

Estimated Salary: $150,000 - $180,000 per year, depending on experience. We offer a hybrid work arrangement, with minimal travel required.