RAS Regulatory Affairs Specialist

The position performs the preparation and administrative portions for

the different regulatory services and deliverables and support

department relative contributes, e.g. the regulatory projects or

Intelligence.

Project Execution

1.Support and perform the preparation and administrative portion for different regulatory services, included but not limited to CTD authoring customization and integration, CTD document preparation and publishing, country paper and electronic submission, gap analysis customization and integration, consultation meeting arrangement, Regulatory project coordination supports and support the liaison with Authority according to the regulatory requirements, service scope and client's expectation.

2.Provide administrative/coordination support and perform regulatory activities including the preparation for the initial submissions and the life cycle for the clinical study and product licenses.

3.Check and collect the regulatory updates and support the regulatory intelligence update.

Commercial Support

1.Support department to prepare the description for proposed Regulatory Service and/or the sales presentation

2.Support department to contributes information for the account

planning process and integrated marketing programs

Preferred Experiences and Skills

1.0-2 years RA related experiences or different subject matter, e.g.

Regulatory operation, CMC or non-clinical discipline and/or eCTD

publishing/submission tasks

2.Understanding country regulatory infrastructure and global

standard, e.g. ICH guideline

3.Good communication, organization, attention to detail.

4. Ability to work effectively with internal and external team.

5.Ability to communicate and write English clearly, concisely, and effectively.