Job 69 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.

DAY-TO-DAY RESPONSIBILITIES:

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.

KEY DILIVERABLES IN THE FIRST 3/6/12 MONTHS:
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.

Requirement

Bachelor degree, major: Pharmacy, Chemistry, Biochemistry (or relevant Science discipline)
Master degree, major:Relevant scientific field or a MBA

Experience:

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 Director