Regulatory Affairs Associate – Temporary Position

Responsibilities

•    Maintenance and update of CMC part in regulatory files. 
•    Review of validation documents for the submissions and update the CMC part in regulatory files.
•    Be involved in multiple projects and provide appropriate regulatory strategy in order to write and support change variations in the best quality
•    To conduct information searches and to communicate on new guidelines.
•    Demonstration of full understanding of regulatory requirements for the biopharma industry (drugs, medical devices, biologicals).

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.

להגשת מועמדות אנא שילחו קו"ח לשרונה סידורנקו: consultant.Sharona.Sidorenko@btgil.com