HireDiversity

Beijing, CN

Regulatory Dossier Solutions Senior Submission Specialist-000008R4

Description

Ø Utilize current electronic document management and publishing tools and submission standards to prepare registration dossiers according to regulatory requirements for paper and electronic submissions.

Ø Provide component-level submission readiness support to ensure submission components conform to e-submission standards (e.g., bookmarking, hyperlinking, minor Word formatting, etc)

Ø QC electronic and paper submissions to ensure compliance with company and agency requirements.

Ø Maintain effective interactions with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components taking into consideration special requirements and needs

Ø Participate on special projects and process improvement initiatives

Qualifications

- University/Bachelors Degree or equivalent preferred
- Business Experience:

o Minimum 6 years overall Business Environment experience required

o 4 years minimum within a Pharmaceutical Regulatory environment required

o Experience working within a global business environment preferred

o Experience working with China Health Authority (SFDA) regulatory registration requirements and guidelines required

o Operational/Submissions experience preferred
- General working knowledge/experience with:

o Electronic submission processing and functionality (bookmarking, hyper-linking, tabs, Dossier Table of Contents creation, PDF renditions, etc); Adobe Acrobat, ISI Publisher or similar publishing tool, ISI Toolbox, and other publishing and dossier processing tools preferred.

o Microsoft Office applications, document management systems preferred
- Language Requirements:

o Required: English Proficiency -Written and Spoken forms
Strongly Preferred: Mandarin Proficiency -Spoken form

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Regulatory Affairs