Abbott Regulatory Affairs Supervisor in Ho Chi Minh City, Vietnam

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com