Company Overview
* Leading Asian player in the Consumer Healthcare Market
* Progressive growth opportunity
Our Client:
Our client, an established home grown brand with diversified business is expanding. As part of their expansion plans in the Asia region, they are now adding a newly created role for their Healthcare team.
Job Description
The role reports directly to the Head of RA/QA, the successful incumbent will be tasked to lead and drive end to end Regulatory affairs activities for the Asia markets.
The ideal candidate should have:
* At least 6-8 years of Regional RA experience in Consumer healthcare or Pharmaceutical background.
* Prior experience in a setting up RA policies and systems
* Capable of leading assigned overseas subsidiaries in product registrations, variation applications, periodic safety updates, etc.
* Good engagement and be key liaison with related regulatory authorities, distributors, consultants and contract manufacturers to ensure good understanding of the regulations requirements and ensure compliance with the regulator trends.
* Develop and maintain product quality, safety, efficacy, license database and standards to ensure regulatory compliance.
Requirements
*Good communication skills with strong stakeholders management experience.
*Bachelor degree in Pharmacy / Chemistry / Microbiology
*Strong familiarity with GMP, ISO and ICH Guidance
*Flexibility to travel overseas for business
*Proficient in MS Office application ie Word, Excel and Powerpoint