Regulatory Affairs Specialist/ Chuyên Viên Đăng Ký

- Coordinate with manufacturers and prepare dossiers for medicine and non-medicine (cosmetic, and food supplement) product registration (Renewal registration, variation registration, new registration) or submission to Regulatory authorities (DAV, VFA);

- Follow to get the approval of marketing authorization, import quota, variations intimely manner;

- Support Business team/Supply Chain in applying for advertisement licenses & detail aid material printing permits;

- Coordinate with Business team/Supply Chain to support for product’s availability on market;

- Supply the required information/documents for requirements of external or internal colleagues including Health Authorities (Ministry of Health) to conform to Company’s regulations and law;

- Develop artwork required for packaging to secure new product launching and secure stock for sales;

- Supervise and support daily workflow of Regulatory Affairs staff;

- Promotional material registration:

• Review promotional material and support Marketing to revise in accordance with Authority’s requirements.
• Submit dossier in time and follow up on the submission process.
• Review product information published on MIMS/VIDAL

- Other duties: Hospital tender support: provide documents (GMP, CoA, CPP, FSC..), official letter (explanation/commitment,.) to support hospital tender application;

- Other tasks are assigned by Regulatory Affairs Director/Deputy Manager.

- Medical/ Pharmaceutical University graduated;

- At least 3-year experience at the same position;

- Good MS office skills (Word, Excel, PowerPoint, Corel/AI);

- Understanding of regulatory rules and regulations of the Ministry of Health;

- Good communication & office administrative skills.

BENEFITS:

- TV TPI is among the top companies with "Best Places to Work in Asia" voted by HR Asia;

- Commitment to paying full social insurance;Hung Vuong health insurance;

- 14 days vacation/year;Review salary periodically twice a year;Bonus 30% of salary when passing probation;

- 13th month salary, seniority bonus, performance bonus (14th month salary), personal achievement bonus, project bonus, departmental bonus,...;

- Bonus on major holidays: New Year 500,000 VND; Ceremony April 30 - May 1: 500,000 VND;

- National Day 500,000 VND; Tet holiday 500,000 - 1,000,000 VND; lucky money at the beginning of the year,...;

- Birthday bonus: 1,200,000 VND;

- Marriage bonus: 2,500,000 VND, childbirth bonus: 3,000,000 VND;

- Mid-Autumn Festival gift: 550,000 VND;

- International Women's Day March 8: 200,000 VND;

- International children's: 200,000 VND (children under 15 years old);

- Vietnamese Women's Day October 20: 200,000 VND,....;

- Periodic health check-ups;Sponsor training costs with courses outside the business;

- Organize internal training courses on pharmacy expertise, skills and functions for all employees;

- Opportunities to work abroad;

- There are Badminton and Arts Clubs to improve the physical and mental health of employees;

- Team building and other activities such as Christmas, Year end party, volunteering,...

• Bằng cấp: Bachelor
• Độ tuổi: Không giới hạn
• Hình thức: Nhân viên chính thức
• Thử việc: 2 tháng
• Thời gian làm việc: Từ Thứ 2 - Thứ 6, 8:00 - 17:00