A global specialty pharmaceutical and medication delivery MNC is seeking for talented professionals to join their team.If you are a dynamic player who is looking forward to work in a diverse environment, an excellent communicator and fits the criteria, send in your application now!!!
Regulatory Affairs Assistant/Associate
• Responsible for regulatory submissions in Singapore and Brunei for pharmaceutical products and medical devices. Therapeutic areas include Women’s & Men’s Healthcare, Diagnostic Imaging,
General Medicine &Speciality Medicine:
• Prepare new, renewal and variation registration applications.
• Answer Health Authority queries arising from registration applications
• Liaise with R&D sites, manufacturing sites and others to obtain data
required in support of registration applications and to answer queries.
• Liaise with third parties in relation to registration activities.
• Maintain regulatory files and records to track progress of registration
applications
• Prepare a schedule of current and planned registration activities
• Provide reports on registration or other activities as required
• Provide maintenance support for existing product licenses.
• Interpret existing and new regulatory guidelines as they relate to company
products, procedures and policies
• Review packaging texts to ensure compliance with registration and legal
requirements & approve packaging artwork as necessary
• Review and approve technical content of promotional materials as necessary
• Supply product information in response to internal and external requests.
• Maintain global databases e.g. Registration Database, PI-Products Database,etc.
• Assist in other regulatory projects from HQ and other divisions
Qualifications
• Bachelor Degree in Life Sciences or Pharmacy
• At least 1 year of relevant experience are preferred
• Good command of written and spoken English
• Computer literacy
• Meticulous
• Able to work independently
• Good time management skills
• Good document organization skills
Interested and qualified candidates, please submit your resume to :
annelim@recruitexpress.com.sg
