Senior Regulatory Affairs Manager

Shanghai - China

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

JOB DESCRIPTION:

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 backgroundetc)

要求

Bachelors 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

N/A

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

JOB FAMILY:

Regulatory Operations

DIVISION:

APOC Point of Care

LOCATION:

China > Shanghai : 388 W. Nanjing Road Ciros Plaza

ADDITIONAL LOCATIONS:

Singapore > Singapore : DUO Tower

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

Required Experience:

Manager

JOB DESCRIPTION:Primary Function职责概述To operate the registration in compliance for China and select countries in Asia Pacific regionTo ensure the registration schedule to meet the business development requirementMajor Responsibilities主要职责1. Lead and complete regulatory registrations to ensure shipm...

JOB DESCRIPTION:

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