RA Submission Officer - Beijing, 中国 - TEKsystems

描述

职位介绍

Position purpose:

The critical outcome is to implement the submission strategy to deliver agreed registration milestones with the high standard of regulatory submission dossier and efficient manner. Interacts with Regulatory Authorities to maintain awareness of current regulatory standards related to submissions for chemical drugs and biologics. Submission Lead/officer is responsible for overall process of submission dossier preparation and submission for all life cycle activities.

Key Accountabilities/Responsibilities

1.Responsible for module 1 documents preparation, such as certificate documents, INN, trade name, patent, etc. Responsible for dossier formatting,

2.Responsible for archiving, ensure that regulatory information management system is updated, and registration documents are archived timely.

3.Responsible for labelling and artwork execution.

4.With support from line manager to organize the kickoff and other cross-functional meetings related to submissions.

5.Provide timely and high-quality regulatory submission support and input to internal key stakeholders such as medical, commercial and GMS site as needed.

6.Continually monitors and collects the regulatory intelligence regarding submission standards/policies and assesses the potential impact to submission processes to ensure compliance and efficiency in the delivery of submissions.

7.Ensure regulatory compliance activities are harmonized with company internal and local policies

8.Assigned other tasks such as SOP/OI/Intelligence Taskforce to contribute comments.

Qualification:

1.Bachelor or above degree in a Life Science related discipline

2.Strong written and oral communication skills in English and Chinese, building strong customer relationships and delivering customer-centric solutions.

3.At least 2year experience in the pharmaceutical industry, preferably in drug development or regulatory affairs.

4.Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, NMPA, CDE, ICH, FDA, EMA etc).

5.Project management skills strongly desired.

6.Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers.

7.Ability to handle time pressure and the consequence of any delay in timely submissions

8.Can work independently, ability to multitask, self-motivated, well organized and adaptable, detail-oriented, able to prioritize and work well with others.

9.Affinity to work with complex IT systems. Strong knowledge with MS Office applications and Adobe Acrobat is required. Strong knowledge with MS Project and electronic document management systems is desirable.