Regulatory Affairs Manager/Associate

באר טוביה |
5-6 שנים |
משרה מלאה
| 24/05/2022
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.