EPM Scientific are currently working with a biotech with an exciting pipeline, who are urgently seeking a Regulatory Affairs Manager to join their team. See a short summary below;


Employment Conditions:

- Start date: ASAP
- Location: Israel
- Language: English is essential, additional languages are a plus


Key Responsibilities:

- Preparing and submitting New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) along with Investigational New Drug (IND) applications and Clinical Trial Authorizations (CTAs)
- Supporting regulatory aspects of clinical trial planning and maintenance.
- Engaging with regulatory authorities such as the FDA, EMA, Health Canada, and others.


Requirements:

- Strong (5+ years preferred) experience in Regulatory Affairs
- Experience working in start-up environments is a plus
- Exceptional written and verbal communication skills.



If this role is of interest to you, please apply directly to learn more about the role. If not feel free to share with your network.