Oanh Trần
Job description
- Process all the new dossiers till submit to DAV within the timeline.
- To prepare and compile registration dossiers as per the specific country guidelines and submit them to regulatory authorities.
- To prepare, review and compile re-registration documents.
- To prepare & review /check artwork, pack insert, SmPC etc.
- To study Regulatory guidelines of assigned countries and to prepare a checklist / template for registration dossiers.
- To verify specification of excipients, active, finished product and packaging material and all required documents.
- Application, review, coordination, follow-up of legal documents COPP, FSC etc.
- Maintain Proper database w.r.t to master document dossier.
- To collect and verify all technical documents and information from various departments at the manufacturing site.
- Provide Regulatory support to various departments.
- Review follow-up and coordination for registration samples /WS and impurities required for analysis purpose.
- To reply to any queries raised by the respective regulatory authority, in a timely manner.
- To maintain and update Registration certificate /information in regulatory databases.
- Be open for Freshers
- Candidates with at least 6 months to 1 year experience in Pharma Regulatory Affairs will be preferred.
- Have knowledge of the field of drug registration to deal with unusual and common problems.
- Have knowledge of drug development, quality control, quality assurance (related to drug registration).
- Excellent PC skills , should be proficient with the usage of the internet as a tool to find necessary & useful information.
- Must be organized- timely, and with information/data.
- Fluent English skills: Communication, Reading, Writing and Translation.
- Salary Negotiable (Based on your experience) and Allowance.
- Opportunity to work in a professional and responsible environment.
- Other benefits of the Company such as training, working equipment.
- To participate in Social insurance, Health insurance and Unemployment insurance according to regulations.
- Full benefits as prescribed by Vietnamese Labor Law.
Job Requirements
Minimum Bachelor’s Degree
Skills
English Languange
Microsoft Office
Attention to Detail
Pharmacy
Teamwork
Communication Skills
Job benefits
Team-building events
Build camaraderie and trust within the companyWellness
A range of self-help services to support you in stressful situationsTravels are free
We partner with transport and airline companies so you can go worry-free travelVacation & Leaves
You can take as many vacations, sick, personal, or mental health days as you need, so long as your manager approves your time off