Manager, Regulatory Delivery Excellence

Description

Partner with Regulatory TA & CMC team members, vendors and other contributing functions to develop submission plans, including dossier lists, timelines etc.

Collaborate with the related functions to ensure effective execution of the submission plan.

Manage RIM-related activities and collaborate with GRA RD&E team to support the submission plan

Escalate issues that may impact submissions and timelines.

Support regulatory TA & CMC teams on submission related activities:

Arrange translations and manage the quality checks of translated materials.

contribute local Module 1 documents to RIM content plans for new MAAs, Line extensions and new indications

Author administrative documents based on guidance from Regulatory scientists

Perform document formatting and manage the quality checks

Compile submission dossiers according to the submission plan

Execute QC testing-related activities, including material ordering, contract execution, and vendor communication etc.

Serve as the Subject Matter Expert (SME) for regulatory business processes and how those are executed in the Veeva Vault RIM system to ensure consistency of process execution and data.

Input and maintain data in China/global IT system, e.g. RIM, China submission archive and maintenance platform, etc.Develop collaborative relationships with personnel in the related functions (e.g. CRP, SC, GPS, Stats, CDTL, CSM, GRA RD&E,etc.) to effectively execute the registration plan.

Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise.

Qualifications

At least bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences

At least 2 year experience in drug regulatory affairs or drug development for manager (P2)

Preferable To Experience In Leading Pharmaceutical Company Good skill on English writing, speaking and listening

Good skill on computer operation

Self-motivated