- Location
- VNM - Hanoi, Vietnam
- Type
- Full-time
- Department
- Legal
- Experience
- 1+ years
- Source
- Workday
Description
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Job Description
About the role:
The job requires the person to manage Regulatory Affairs for allocating products to ensure they are following statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of Business Vietnam objectives through active assistance in the development and implementation of the company’s policy positions and product advocacy strategies.
How you will contribute:
* Reporting to the Senior RA manager to implement Regulatory Affairs activities
* Implement product registration strategies in line with company goals and registration plan and handle product registrations for assigned products.
* Network with and establish influential relationships with key regulatory authorities to ensure a smooth and efficient registration and advertising approval process.
* Actively monitor the regulatory environment, including competitor regulatory activities. Develop appropriate response/action and manage accordingly with internal stakeholders. Work with external consultants to influence positive changes of the regulatory environment.
* Implement local regulatory SOPs to ensure the compliance with local, regional, International and Corporate regulatory SOP’s and other processes to maintain good corporate practice and company reputation.
* Be the legally responsible person for Company regulatory licenses e.g. import, sell and product licenses for the assigned products.
* Provide appropriate regulatory and technical expertise to support sales and marketing activities.
* Complete relevant reports within designated timeframes.
* Manage timely submission of PSUR/PBRER to the regulatory authority for the assigned products.
* Convey changes in product license status and pharmacovigilance related license commitments to the PV department.
Skills and qualifications:
* University Degree on Pharmacy/ Medicine.
* At least 1-2 years of experience in regulatory function in the pharmaceutical industry
* Proactive and highly committed to support and deliver results
* High Sense of Ownership and accountability for achievement
* Highly organized and self-disciplined
* Good interpersonal skills- capable of working and relating with competent authorities
* High level of integrity and good morals.
* Innovative and resourceful with good analytical and problem-solving skills
* Good communication and facilitation skills
* A good team player with good interpersonal skills
* Good written and oral communication skills in English
* Computer literate with proficiency in MS applications
