Regulatory Officer (level 3)

Location Ho Chi Minh City, United States
Industry Others
Category Others
Job reference 10337
Job type Permanent
Consultant email hang.cao@manpower.com.vn
Consultant contact no +84 28 3911 0950
Date posted Oct 21, 2020
Duties:

1) Routine responsibilities
a. Develop and facilitate relationships with key Regulatory Authorities and decision-makers; discuss and challenge issues and negotiate solutions in the best interests of the company.
b. Conduct and document regular performance reviews and an annual review as well as regular personal / career development discussions with direct reports.  
c. Provide on-going training, support and development team member of the Regulatory Affairs Department (in case we have a Regulatory department).
d. Administrative support  
e. Maintaining system and experience management program  
f. Preparing regular management reports  
g. Other projects that may be assigned, outcome: Efficient administration of global programs; timely, accurate, complete database and reports.  
h. Develop and maintain a learning program for the effective communication and training on Compliance Policies owned by Compliance. Work with BM, BUM, TSR, Legal, Finance, HR, and other functions to plan and implement compliance and ISO programs, experience management, ORK, KPI, systems, and internal communications. Support the functions in ensuring that their compliance policies are communicated, implemented and enforced.

2) Corporate Technical Support
a. Member of the Team that works for ISO certification and ensures    current compliance.
b. Support to develop registration strategies, prioritize assignments, implement regulatory plans, adhere to local regulatory guidelines and requirements and coordinate multiple projects and activities in accordance with company’s strategic objectives.
c. Support activities related to company and product licenses 
maintenance and resolution of relevant regulatory issues.
d. Maintains awareness of changes to laws, regulations and requirements and keeps company informed of changes.
e. Support the maintenance of relevant record and systems whilst ensuring timely updates as governed by SOPs.

3) Inspection of Incoming Shipments a. Ensures that all incoming raw materials are inspected according to established SOP.

4) Communication
a. Interact and participate in discussions on regulatory matters concerning company’s portfolio/interest and also involve in building rapport with Regulatory Authorities and Industry Association, as appropriate.
b. Monitor, analyse, interpret and inform respective departments regarding regulatory trends and events including matters such as regulatory guidelines, regulatory environment/issues, regulation and external meetings concerning regulatory matters.
c. Support relevant departments to anticipate changes in country registration policies and guidelines and keeps relevant departments informed of changes in the regulatory environment.

5) Management
a. Develop systems and process improvements to continuous improvement.
b. Participate in and promote team building and provide a stimulating environment which encourages team and individual growth.
c. Effectively plan and monitor self-performance to meet set objectives. d. Own self-development, performance management and career planning.

6) Regulatory Compliance
a. Be accountable for regulatory compliance (of records and systems) within the area of responsibilities.
b. Complete relevant training activities and comply with relevant standards in the office.
c. Ensure registered products are maintained in full compliance with all relevant legislation and SOP procedures. 

General Required Regular Reports/Outlooks

1) Regulatory Reports
a. Generates RMIR (Raw Material Inspection Report)
b. QA Delivery Inspection
c. Regulatory Weekly Report d. FDA Status
e. Complaint report (as necessary) 

Specific responsibilities for YOU 

INTERNAL
1) QC form processing for clients with additional requirements other than COA attachment.
2) QC form approval for usual delivery.
3) Inspection of raw materials prior delivery.
4) Inspection of incoming shipments.
5) Technical assistance to TSRs – providing import stats, analysing COAs, neutralization of COAs, communication with suppliers.
6) Patent research.
7) Maintain ISO documentation records.
8) Function as a member of the claim team to handle suppliers’ communication.
9) Process client audit request.
10) Functions as a member of the temp mapping execution team.

EXTERNAL
1) Inspection of shipment delivered direct to clients.
2) FDA applications for add source, FDA - BOC import clearance for pharma samples and other FDA task related hereto. 
3) Technical assistance to TSR’s – complaint verification, product information assistance. 

Qualifications Required

1) Licensed Food Technologist or Chemist with at least four years practical experience, both in regulatory and manufacturing functions.
2) Able to compose routine correspondence.
3) Able to interrelate and maintain good working relationship with all departments in corporate environment.
4) Meticulous, energetic, systematic, self-driven, able to work with minimum supervision; ability to report to superiors without prodding.
5) Cheerful disposition; does not wilt under pressure in our fast-paced trading environment which requires speed and a getting things done promptly attitude – no tendency to procrastinate.  
6) Good command of written and spoken English.
7) Computer literate at least in Windows environment.
8) Capability/potential for acquiring higher responsibilities