Regulatory Affairs Manager/Associate –Position - DP10
Regulatory Affairs Manager/Associate –Position - DP10
חברה:
חסוי
תחום:
ייצור ותעשייה
כימיה / ביולוגיה / ביוטכנולוגיה
מחקר, מחקר ופיתוח
ניהול
תאור תפקיד:
- 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 וניסיון נדרש:
- 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.
היקף המשרה:
משרה מלאה
למשרה זו, קורות החיים ישלחו ישירות למעסיק. רק פניות מתאימות תענינה.
משרה זו סגורה ולא ניתן לשלוח אליה קורות חיים.
סגור