Regulatory Affairs Manager
1 day ago
We're looking for a Regulatory Affairs Manager cum Chief Rep for our client's Rep Office in District 3, HCMC. Our client is a BioPharma company in China.
**Job Summary**
Filling the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner.
Make sure the accuracy and truthfulness of the registration dossiers. Maintain the registration and approved dossiers per company requirements.
Establish and maintain the good and closed relationship with DAV. And successfully gains product Marketing Authorization per registration forecast plan.
Provide the cross cooperation with other departments
Establish and maintain the good relationship with key contacts and clients. Recommend valuable suggestion to company. Take a role of a Chief Rep for their Rep Office
**Main Tasks & Responsibilities**
Prepare the registration dossier to submit to DAV and obtain the approval to meet the registration plan.
Make sure the accuracy and truthfulness of the registration dossiers and maintain all the submission and approved dossiers in related IT systems, and notify all the stakeholders per company SOP requirements.
Assistant to the group RA team, interact with Global/regional development team to achieve strategic company goals.
Assistant to the group international business division, provides information to the assigned project planning and regulatory strategic plans in cooperation with global/regional/local staff to achieve and optimize strategic company goals.
Initiatively deal with daily works. Keep records. Have clear filing and maintain of all
documents, update in RA related IT systems, share points on time.
Other projects or tasks assigned by line manager.
**Education & Qualifications**:
Pharmaceutical companies or regulation authority background.
Familiar with pharmaceutical product regulation.
Fluent English or Chinese in listening, speaking, reading and writing.
Good skill on computer, MS-Office operation.
**Experience and other requirements**:
Have not less than 5 years’ experience in pharmaceutical regulatory affairs.
High enthusiasm and devotion, work hard and earnest
Be honest and open, excellent interpersonal communication skill, ability of social activity and collaboration
Innovating with good independent working ability
Energetic team spirit
**Salary**: 30,000,000₫ - 55,000,000₫ per month
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