Director, Global Regulatory Affairs – Rare Disease Programs

Larimar Therapeutics Inc.; Philadelphia (Philadelphia County); Presencial; USD 180.000 - 280.000; Jornada completa

Descripción de la vacante

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on rare diseases using its cell penetrating peptide platform. The Director, Regulatory Affairs, will support global regulatory strategy and drive regulatory activities for products in development, with emphasis on European and other global regions.

The role reports to the Regulatory Affairs Senior Director. The successful candidate will lead regulatory submissions to health authorities, provide tactical

Formación

• Bachelor's degree required.
• 5–8 years in Regulatory Affairs in the pharmaceutical industry.
• Experience with EMA/MHRA and European agencies preferred.
• Strong written/verbal communication and project management skills.

Responsabilidades

• Define, develop and lead global regulatory strategies for complex development projects.
• Provide tactical advice to project teams to ensure timely submissions and approvals, ensuring compliance with global requirements.
• Lead regulatory submissions to ex-US health authorities (e.g., EMA, MHRA) and alignment with global strategy.
• Collaborate with Commercial, Medical, Legal and Compliance on advertising materials and OPDP submissions.
• Prepare regulatory impact assessments of global intelligence, including ICH and global guidances and FDA advisory committee meetings.
• Develop internal regulatory procedures and practices.
• Serve as backup to other global regulatory activities under RA Senior Director.

Conocimientos

Regulatory strategy

Project management

Communication

Cross-functional leadership

Global regulatory submissions

Educación

Bachelor's degree

Descripción del empleo

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on rare diseases using its cell penetrating peptide platform. The Director, Regulatory Affairs, will support global regulatory strategy and drive regulatory activities for products in development, with emphasis on European and other global regions.

The role reports to the Regulatory Affairs Senior Director. The successful candidate will lead regulatory submissions to health authorities, provide tactical