Regulatory Affair Supervisor

cap LP & Associates' client

post time Posted 71 months ago

Position	Regulatory Affairs Supervisor
Function	Regulatory Affairs
Location	Travel between HCM & Binh Duong
Reporting to	Regulatory Affairs Manager

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 shelflife.
• 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.