The candidate will provide RA consulting services to meet client expectations by supporting the design and development of products from a regulatory perspective, actively contributing to the development of regulatory strategies for product development and approval as well as product lifecycle. Writing regulatory submissions to authorities globally (i.e US, EU, and Israel). Reporting to RA Director
Regulatory affairs Consultant
· M.Sc. or Ph.D. in Life Sciences/Biotechnology & Biomedical Engineering.
3 years of experience in medical device or pharmaceutical development- advantage
· Enthusiastic and eager to learn new development technologies and products
· Excellent scientific writing and data mining skills
· Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
· Excellent verbal and written communication skills enabling interacting with customers with a service-oriented attitude, understand customer needs and challenges, and adapting accordingly.
· Experience in interacting with QA, QC, and CMC teams- advantage.
· Ability to capture both the "big picture" and technical details.
· Ability to adhere to timelines, act with a sense of urgency in an environment requiring rapid and prompt responses.