Regulatory Affair Specialist (Contract Staff)
Skillpower Services (Thailand) Co., Ltd.
jobsDB ref: JTH300003001253030
Regulatory Affair Specialist ( 2 Year )
Location: Ladkrabang Johnson & Johnson (Thailand) Ltd
Job responsibilities :-
Responsible for product registration, regulatory data management and coordination on new MDD project assigned from manager.
To prepare registration dossier, execute the submission and interact with TH FDA officer to obtain product licenses of assigned franchises in full compliance with Thai FDA regulations
To manage registration information and ensure all database are up-to-date on timely manner in accordance with internal SOPs
To drive reduction of cycle time for new product registration and on time license renewal
To work closely with Sourcing companies, Supply Chain, Sales & Marketing and Quality team of relevant issues
Any other duties as assigned by Supervisor
- Bachelor’s degree in Pharmacy/Science/ Medical Science
- Preferably with experience in medical device or pharmaceutical product registration
- Responsible, hard-working, well-organized
- Sense of urgency
- Good command of English both writing, listening and speaking
- Good analytical and problem solving skills
- Good technical and professional knowledge, including computer skills
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About Skillpower Services (Thailand) Co., Ltd.
Manpower Inc. is a world leader in the employment services industry, offering customers a continuum of services to meet their needs throughout the employment and business cycle. The company specializes in permanent, temporary and contract recruitment; employee assessment; training; career transition and organizational consulting services. Manpower''s worldwide network of 4,500 offices in 80 countries and territories enables the company to meet the needs of its 400,000 customers per year, including small and medium size enterprises in all industry sectors, as well as the world''s largest multinational corporations. The focus of Manpower''s work is on raising productivity through improved quality, efficiency and cost-reduction, enabling customers to concentrate on their core business activities. In addition to the Manpower brand, the company operates under the brand names of Right Management Consultants, Jefferson Wells, Elan, Brook Street and Empower.
Manpower Thailand is the nation’s leading recruitment company established in 1998 to offer human resources management services to businesses in search of staff and people in search of job. The company currently has 10 offices in Thailand cover in Bangkok, Chonburi, Lamphun and Songkla to cover the needs of corporate clients and job seekers.