Regulatory Affairs Compliance & Project Specialist (2-year Renewable Contract) [Innovative Medicine]

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com

Job Function:
Non-Standard

Job Sub Function:
Fixed Term Employee

Job Category:
Non-Standard

All Job Posting Locations:
Mongkok, Kowloon, Hong Kong

Job Description:

Overall purpose of job:


* Maintain regulatory compliance and system compliance.


* Ensure training assignment is appropriate and timely.


* Support Regulatory Affairs Team on labeling project and other ad hoc project(s) where applicable.

Key responsibilities:
Regulatory Compliance:


* Archive regulatory documents and Health Authority correspondence.


* Maintain regulatory documents and update information in regulatory system.


* Maintain regulatory trackers and metrics.


* Adopt regulatory requirement compliance practice: fortnightly review of Health Authority Regulations, Guidelines and Policy updates.


* Monitor Global and Local SOP updates and training metrics.


* Support Regulatory Affairs Lead to build and create process, ensure compliance to regulatory requirements as well as internal company standards.


* Monitor HK Macau NCE registration status.


* Prepare quality metrics of QSMR.


* Renew product certificates, support product deregistration and manage related change controls.


* Renew company licences issued by the Health Authority.


* Supply statistics on Dangerous Drugs.


* Support Macau regulatory submissions.


* Provide administrative support for licence payment, document legalization.

System Compliance:


* truVault Document Controller: Manage the document workflow under truVault.

Create workflow, upload draft document and route for approval.


* Corporate Entity Management System (CEMS): Upload Dangerous Drug Licences to the system.


* SUMMIT Training System Administrator: Assign training according to LOC training matrix to other functions for Regulatory Affairs.

Labeling Project


* Submit and obtain mock-up, production artwork approval in labeling system.


* Support labeling review, eg using TVT system.


* Monitor and implement labeling components.


* Coordinate with supply chain to ensure effective launch for labeling changes and new product launches.

Required Qualification and Core Competencies for the role:

• Associated degree in science.

Bachelor's degree in science is preferred but not a must
• 1 to 2 years work experience, preferably in administrative work.
• Proficiency in both spoken and written English and Chinese.
• Candidates who wish to...