Regulatory Affairs Manager

NeuroSense Therapeutics is seeking a Regulatory Affairs Manager to join our team.

A significant part of this role is composition and maintenance of CMC, pre-clinical, and clinical sections of regulatory submissions documents, as well as composition and review of briefing packages, clinical protocols and Investigator Brochures.

Ideal candidates will enjoy cross-functional project management and working both independently and collaboratively. Key aspects of this position include preparations and submission of NDAs/MAAs, INDs/CTAs, regulatory involvement in Phase I/II/III clinical trials planning and maintenance, and meeting with regulatory authorities (FDA, EMA, Health Canada and others). 

If you possess these skills and are passionate about developing drugs for unmet medical needs, we encourage you to apply.

Requirements

• BSc or MSc
• 8 years+ of experience in biotech sector & regulatory affairs
• Proven skills of regulatory affairs in drug development
• Working knowledge of international (FDA, EMA, HC) and local (iMOH) regulations
• Excellent organizational, management, and interpersonal skills
• Ability to excel in a dynamic work environment
• English - Mother tongue, written and verbal
• Responsible, self-motivated, organized, and meticulous