Assistant RA Manager - Pharmaceutical

Purpose of the position

[Regulatory affair]
* Secure 100% compliance according to local regulatory requirement regarding license matter
* Increase the speed for product registration, management of product variations and ensure the maintenance of current product licenses
* Ensure product quality control according to local authorities and Astellas Headquarters QA’s requirement

[Pharmacovigilance]
* Develop and maintain an effective pharmacovigilance reporting process and ensure that all data is kept in an inspection and audit ready state at all time

Key responsibilities and tasks
* Liaise with relevant parties and authorities for product and new indication registration
* Manage all product and license registration related issue in Singapore, Malaysia, Sri Lanka, and Myanmar
* Communicate with local healthcare authorities and Headquarters RA department
* Update of package insert or labelling change
* Support for HSA inspections
* Safety information reporting to local authority and Headquarters PV
* As a Drug Safety Officer (DSO) of company, responsible for all tasks and responsibilities described in the role description of DSO
* Creating, revising and provide regular update for local PV SOPs
* Creating and revising PV agreements with distributors, licensers and investigators
* Validity check of safety reports received
* Prepare and submit monthly compliance report to HQ PV
* Preparation for PV inspections

[Quality assurance]
* Creating, revising and provide regular update of local quality related SOPs
* Creating and revising quality agreement with distributor and licenser
* Product release for each new shipment
* Monitor storage condition of samples stored in company office to comply with requirements of local authorities
* Handle quality complaints and enquiries
* Preparing QA actions plan and review
* Preparation for QA audit
* Change control of company products
* Support and coordinate all actions needed in case of product recalls

Requirement
[Education and experience]
* University graduates with major in life science related background
* At least 3-5 years relevant experiences in pharmaceutical product registration and regulatory affair job
* Local registered pharmacist is preferred
* Proficient PC skills and analysis tools including Word, Excel and PowerPoint

[Business understanding]
* Previous exposure to sales and marketing function is definite an advantage
* Self-motivated and be able to work independently
* Fluent in spoken and written English

[Soft skills]
* Able to work with team and cross function
* Pleasant personality

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the pharmaceutical and medical devices industry, please contact Jennifer Ha at j.ha(@)realstaffing.com or contact +65 6871 4700.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:
International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Gloabl Recruiters 2017

Application Email: JIHA.01484.3273@sthreesg.aplitrak.com