Regulatory Affairs Supervisor

Location: Ho Chi Minh City, Vietnam
Job Type: Permanent
Salary 13th
Specialization: Life Sciences, Healthcare, Medical Devices & Pharmaceutical
Sub Specialization: Regulatory Affairs
Contact: Thi Hong Tham Nguyen
Reference: JO-1804-393245

RESPONSIBILITIES
* Manage personnel of RA Department.
* Build the standard system to evaluate working position, achievement, capacity of employee.
* Get product registration plan and assigned task directly from RA Manager.
* Refer to the products which have similar dosage form, strength, packing form, package material and shelf-life.
* Refer to reliable documents from official sources to find out clinical, pharmacology, pharmacokinetic characteristics… of active ingredient and product.
* Assign and distribute preparation of new/renew variation/supplement domestic/export product registration dossiers according to current technique and regulation.
* Prepare new/renew, variation/supplement domestic/foreign registration dossiers, visa number extension, commitment to maintain effective of visa number, Food supplement dossier, advertisement dossier.
* Check registration dossier by soft and hard file before submitting to DAV.
* Prepare leaflet with bilingual Viet-Eng content.
* Translate documents from Vietnamese into English and opposite way as requested.
* Follow up deadline of renew registration, make plan, assign and operate preparation of renew domestic/ export registration according to periodicity.
* Follow up progress of registration and promote implement.
* Follow up, receive information/ feedback from Drug Administration of Vietnam (DAV), Vietnam Food Administration (VFA) - Ministry of Health (MOH) about registration supplementary dossier, Decision of Visa number Issuance as well as approval official letter for changing/supplement.
* Follow up searching and updating information about Drug/ Food supplement regulation as well as regulatory affairs.
* Official Pharmacy Regulation Training.
* Regulatory affairs Training.
* Follow up updating regulation/ decision/ circular/ official letter related to product registration, manufacturing and circulation.
* Follow up or prepare/ update directly SOPs, forms and other documents related to regulatory affairs.
* Control achieve, management of registration dossiers and other dossiers, documents.
* As information link between authorities/ Pharmaceutical/ Food supplement department and relevant departments.
* Support and guide relevant departments in implement of requested dossier/ document in registration dossier comply with general technique guideline and current regulation.
* Send requests to relevant departments to carry out requested contents in registration dossier.
* Request, follow up, promote searching and protecting trademarks of company.
* Responsible for activity and working of RA Department to RA Manager.
* Coordinate with relevant departments to implement well plan.
* Organize, assign and distribute employee to implement work of department.
* Evaluate KPI based on working efficiency of employee.
* Propose for employee to be joined training course as well as seminar related to regulatory affairs.
* Sign and solve documents in assigned scope.
* Guide to relevant departments about dossier/ document requested in registration dossier to comply with current regulation and general technique guideline.
* Check and decide modification and sign relevant parts in registration dossier.
* Propose to be joined training course about Pharmacy regulation/ Regulatory affairs.
REQUIREMENTS
* Pharmacist Bachelor or higher.
* At least 03 years experience at equivalent position.
* Trained Good Manufacturing Practice (GMP), Environment Health Safety.
* Management and operation skills
* Data analysis and processing skills.
* Writing and presentation skills.
* Proficient computer skill.
* English skill: Good at listening, speaking, reading and writing.