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Regulatory Affairs Manager-#69

Client Information


Job Information

Regulatory Affairs Manager

Job Description

  • Secure timely approvals for new applications and renewals for product registration/notification and permission for raw materials to support the Business Grid and Commercial plans.
  • Ensure regulatory compliance of Company products, raw materials and activities with the current regulations enforced in Vietnam.
  • Timely communication to the Company on changes in Regulations that impact Company and identify opportunities to influence rule making for positions beneficial to Company.
* Core responsibilities:
  • Ensures regulatory efficiently support the business grid and commercial plans by securing timely registration/notification approvals.
  • Ensures compliance of Company products and relevant ingredients with the current regulations in Vietnam.
  • Supports regulatory requestsand relevant regulatory affairs matters of Company Global plant in Vietnam.
  • Develops and communicates short and medium and long term regulatory strategy to enhance growth and business performance.
  • Develops networking with relecant government bodies and trade associations and identify opportunities to influence rule making for positions beneficial to Company.
  • Coordinates activities closely with other CP Regulatory Affairs personnel in ASEAN to ensure Company's strategy for regulatory compliance across ASEAN is streamlined.
  • Communicate to the relevant internal stakeholders on changes in Regulations and regulatory requirements relevant to Company.
  • Compiles and/ensure timely completion of dossier compilation and submission of product registration and notification applications to the government to for timely approvals to meet the business needs / grids.
  • Utilizes GDS system and serve as localadministrator of the system, to support product applications
  • Approves claims and provides support in claims approval process.
  • Approves product artworks and advertisements.
  • Conducts regulatory assessment as required by local, regional or global teams.
  • Assesses claims substantiations
  • Draftsresponses to government inquiries and ensures tracking of responses
  • Compiles Product Information File (PIF) for cosmetic products, as needed and attends to PIF audit by the government.
  • Assists the plant or Customer Service and Logistics in government audits relevant to Regulatory such as GMP audit and Good Distribution Practice audit.
  • Attends to government requests and supports the drafting of responses to government inquiries where relevant to Regulatory and tracking of responses.
  • Meets regularly with relevant internal stakeholders e.g. Legal, Marketing, Customer Service & Logistics and others to discuss on project up-dates and relevant matters.
  • Supports the relevant departments in addressing regulatory issues as necessary including interfacing with the government agencies on these issues.
  • Participates actively in trade association meetings and relevant technical / scientific committees in the association to influence rule making relevant to Company business.
  • Builds and network with relevant agencies relevant to Company.
  • Conducts Regulatory Intelligence, as needed provide Regulatory management with competitiveandnew legislative news.
  • Keeps abreasts on latest regulatory developments in Vietnam and ASEAN and assesses the impact to Company
  • Develops efficient filing system and maintains and keeps up to dateregulatory filesto support anefficientregulatoryoperation
  • Works with the Global Technology group to retrieve appropriate scientific information.
  • Provides periodic regulatory updates/reports to local Management as well as Regional and GlobalRegulatoryAffairs.
  • Works closely with a contact person in the Global plant to attend to registration documents/supports requests by importing subsidiaries.
3 Months:
  • Demonstrates strong knowledge on formulation and technical aspects of products relevant toCompany
  • Develops activity grid, timetable to accomplish Regulatory objectives to meet the business needs.
  • Develops Responds timely to requests (per Regulatory KPIs) either frominternalof external parties (government).
6 Months:
  • Demonstratestheability to communicate ideas and information effectively either verbally or in writing to all stakeholders and in a timely manner.
  • Applies scientific and regulatory knowledge in all aspects of the job including conductingassessment, innovation, problem-solving, and troubleshooting.
  • Participatesin Trade Association meetings where applicable
12 Months:
  • Develops good working relationship with relevant government authorities.
  • Shares internal and external regulatory knowledge and discoveries with colleagues and Commercial Groups through documentations, presentations and meetings.
  • Demonstrates creativity to shorten registration or regulatory approval leadtime where possible, or the best possible regulatory approval route to simplify regulatory process.
  • Bachelor degree, major: Pharmacy, Chemistry, Biochemistry (or relevant Science discipline)
  • Master degree, major:Relevant scientific field or a MBA
  • 2 years of Consumer Goods Industry Experience Required
  • Min 4 years of Functional Experience Required
  • Position Specific Requirement, if any: 2 years of Trade Association Involvement Experience Required

General Information

Ho Chi Minh



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Regulatory Affairs Manager job closed

Mr. Nam Hoang



Regulatory Affairs Manager


Ho Chi Minh


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