Senior Regulatory Affairs Manager

Primary Function

职责概述

• To operate the registration in compliance for China and select countries in Asia Pacific region
• To ensure the registration schedule to meet the business development requirement

Major Responsibilities

主要职责

1. Lead and complete regulatory registrations to ensure shipment of product within the Asia Pacific region.

2. Be responsible for registration projects for the designated countries in the region.

3. Solve requests for additional information and issues/questions from regulatory agencies and governments to meet submission requirements.

4. Ensure that new registration projects are scheduled and that we achieve the  expected schedule.

5. Ensure the renewal license and change application on time.

6. Provide regulatory intelligence updates for regulations, standards and guidance documents to ensure that the organization takes actions to remain compliant.

7. Provide the requested explanation for regulatory changes and any applicable training to global or local cross group if necessary, from regulatory side.

8. Communicate with cross functional teams such as Quality Assurance, R&D, Marketing, Operations and others as required to ensure that complete and accurate information is submitted for submissions and that regulatory requirements are communicated to the organization.

9. Assist to ensure that the registration procedures and SOPs are clear, concise and aligned with current practices and requirements.

10. Provide related regulatory support to other company personnel.

11. Develop and maintain good relationships with related authorization agencies and relevant industry association to build advocacy.

Requirement(education, background,…etc)

要求

• Bachelor’s degree or above
• Above 10 working experience and minimize 2 to 4 years of relevant RA management experiences
• Good English speaking and written and communication skills.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.