Our client is the Asia HQ of an European pharmaceutical company. It focuses on product commercialisation of specialty therapeutic products. With over 3500 employee in 13 countries in Asia Pacific, our client is poised for a significant growth. Aligned to their recent business expansion, they are seeking to hire suitable pharmaceutical professionals as Regional Regulatory Affairs Executive (Asia Pacific)+ To coordinate and manage regulatory issues in relation to acquired brands within Asia Pacific region. + To provide technical support across the region as required in relation to acquired brands. + To perform HQ function for acquired brands and ensure compliance to obligations accruing to being product owner. + Coordinate with individual regulatory departments across the region, with respect to regulatory activities of proprietary or in-licensed brands. + Develop, maintain and update the processes for product registration, transfer of in relation to the acquired brands. + Ensures that requirements and standards are understood within the company and individual markets. + Coordinate and provide regulatory guidance to local and international regulatory staff on registration requirements in relation to the acquired brands. + Manage preparation and submission of initial and renewal product registrations. + Represent the company at various meetings with Regulatory Bodies. + Initiate and update regulatory plans for assigned projects and assist in the development of strategic plans.
+ Review and approve labels, artwork and promotional materials re regulatory compliance.
+ Coordinate with manufacturers with regards to technical documents; updates, change control, development of ACTD + Project Management To be considered for this role, you should have the following Qualifications and Experience: + Bachelor degree in pharmacy or lifesciences from a reputable university + Strong regulatory background, preferably with at least 2 years of Regional Regulatory experience in a pharmaceutical MNC + Working knowledge of an Asian language advantage + Registered pharmacist an advantage + Able to effectively influence and collaborate with people at all levels + Proficient in both oral and written English, computer literate To apply please email your latest resume to firstname.lastname@example.org. We thank all candidates in advance and regret that only short listed candidates will be notified.