Regulatory Affairs Manager/Associate –Position (September 2020)

Responsibilities

  • 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

 

Qualifications

  • 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

olga.geler@ferring.com