Regulatory Affairs Project Manager in Biotechnology

Regulatory Affairs Project Manager in Biotechnology in GSAP.

Company Description

Gsap is an international consulting firm for healthcare companies, providing end-to-end services throughout the life cycle of medical products. Founded in 2009 by Sigalit Ariely-Portnoy, PhD, Gsap leads complex projects in the healthcare industry. The company aims to enhance the development of healthcare companies and empower them to achieve therapeutic solutions for patients worldwide.

The position will include clients’ regulatory support through product development, preparation and submission of regulatory files for various applications and programs.

Requirements:

M.Sc. or Ph.D. degree in Life Sciences

Proven regulatory experience of at least 5 years working with leading regulatory authorities, preferably in Regulatory Affairs managerial positions

Early-Mid clinical stage products

Experience with combination products – an advantage

Profound understanding in product development and diverse CMC subjects – an advantage

English at mother tongue level