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Regulatory Affairs Manager

3 months ago

Hanoi, Vietnam PERSOLKELLY Vietnam Full time

Location: Hanoi
- Salary: Negotiable
- Industry: Pharmaceuticals

**JOB DESCRIPTION**:

- Report to: Board of Directors
- Manage 3 staffs

**Core Responsibilities**:

- Complete submissions to MOH regulatory entities.
- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Other duties as assigned
- Maintain corporate confidentiality at all times.

**Specific Duties and Responsibilities**:
**_1. Regulatory Affairs Operations:_**
- Follow up registration progress, advise on the submission strategy and initiate actions accordingly until the final results.
- Review advertising and marketing/promotion materials for appropriateness and compliance to regulatory requirements and laws.
- Supervise outsource Regulatory Affairs consultants if any.
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
- Review redressing, labeling and sub-labeling practices for compliance with regulatory requirements.
- Provide the regulatory reviews of customer complaints and define the regulatory reporting procedures (flow, timeline, content, etc.)
- Always update information and knowledge of Vietnamese’s MOH and international regulations, guidance and standards and advise the changes to be applicable to company’s products and procedures.
- Plan and implement periodical evaluation of regulatory compliance of document/ product/ processes.
- Conduct Regulatory Affairs training to relevant staff members of the company if required.
- Ensure KPIs that assigned for RA department by the BOD are met.
- Maintain corporate confidentiality at all times.
- Other duties as assigned by BOD

**_2. RA team management:_**
- Define personnel need for RA department, review JD, interview, select and train new employee to meet RA department’s requirements.
- Develop product registration plan and assign tasks directly to RA executives or team members.
- Assign and evaluate KPI for RA department subordinates. Corporate compliance responsibility: Every staff of the company is accountable for assuring compliance’s rules & ethic code all the time while meeting with relevant parties and people to maintain and strengthen company’s image

**JOB REQUIREMENT**:

- Bachelor's degree or Master in Pharmacist Experience
- Approximately over 3 years relevant experience within the regulatory affairs in pharmaceutical industry at senior level.
- Good knowledge of Viet Nam regulatory requirements
- Have good relationship with DAV officer is a plus, well known network, working process of DAV - MOH
- Others: Good communications, Open-minded, Collaborate, Maintain a sense of urgency

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