לצערנו המשרה כבר לא בתוקף

Regulatory Affairs - משרה זמנית עם אופציה לקבועה

1-2 שנים |
משרה מלאה
| 31/01/2021
תיאור משרה

•Responsible for regulatory submissions, approvals and compliance for worldwide market expansions and renewals
•Full understanding of regulatory file template and ability to maintain and update the quality part (CMC sections) in regulatory file
•Evaluate change requests and regulatory impact and establish the appropriate strategy for the projects at BTG
•Ability to write variations/ supplements and to drive approvals globally
•Maintain collaborative work with regulatory teams within BTG and globally
•Provide regulatory support to development activities and drive clinical trial application under development projects
•Review and approve Protocols, Reports and Validation documents
•Responsible for continuously acquiring new knowledge and finding innovative solutions to regulatory challenges and issues
•Provide regulatory CMC intelligence to cross-functional teams
•Demonstration of full understanding of regulatory requirements for the biopharma industry (drugs, medical devices, biologicals) and demonstrate regulatory CMC expertise

דרישות התפקיד

•Academic degree in science (MSc or PhD) in any area of biology, life sciences or molecular biology - must
•Hebrew and English at mother tongue level, with proven abilities in writing and editing of submission documents – must.
•At least 5 years experience in the pharma industry, or 3 years in regulatory affairs and product registration of pharma products – must
•Excellent oral and written communication skills, with ability to work as part of a team- must
•Scientific understanding of CMC requirements and submission content concerning product quality- an advantage
•Ability to simultaneously manage and drive multiple projects to achieve new registration and support change variations - must
•Ability to work independently, work under pressure and to meet changing deadlines- must
• Logical thinking, assertiveness, creativity and flexibility - must
•Computer literacy, including experience with Microsoft Office Word, Excel and Power Point.
•Understanding of GMP and Quality System requirements – an advantage
•Computer literacy, including experience with Microsoft Office Word, Excel and Power Point.
•Knowledge of and experience with US and EU regulatory requirements for the biopharma industry (drugs, medical devices, biologicals) - an advantage.