Job Description:

• Regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements. (US and other advanced markets).

• Electronic Document Publishing (i.e. PDF file preparation as per eCTD requirement, bookmarking/linking, compilation/publishing in software)

• Regulatory maintenance activities

Skills/Knowledge Required:

• Technical knowledge of electronic publishing systems and software

• Proficiency with MS-Office, Excel, power point and Adobe Acrobat applications

• Knowledge of Electronic Document Management Systems

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.