Pharmaceutical Regulatory Affairs TRAINEE at Stresert Services Limited

Our client is an International Pharmaceutical Company.  They seek the service of a Graduate Trainee for a 6 months contract only to support the Regulatory Affairs Unit.

Department: Regulatory Affairs, Global Drug Development   (RA GDD)  

Reports to: RA Head, (English West Africa)

Job Purpose:

• Regulatory Information Management Systems: DRAGON clean-up activities for migration to the organizations Regulatory Information Management System (RIMS)
• Support Lifecycle maintenance of registered products
• Support registration of new products
• Contributes to the planned roll out of the new Regulatory Information Management System

Major Accountabilities:

• Support DRAGON clean-up activities
• Validate data in DRAGON
• Support the organizations Regulatory Information Management System (RIMS)project work stream in the migration of attributes from DRAGON
• Regulatory lifecycle maintenance: Support the RA team in maintaining registration of currently approved products and submission/follow up of New Drug Applications

Ethics and Compliance:

• Works within Ethics and Compliance policies and ensures those around him/her do the same
• Works to ensure a diverse and inclusive environment, free from all forms of dis-crimination and harassment

Key Performance Indicators:

• Validate Data in DRAGON
• Accurate maintenance of registered products database
• 100% migration of attributes from DRAGON to the organizations Regulatory Information Management System
• Achievement of over 95% of DRAGON compliance in updating it with normal country folder Post Distribution Changes (PDCs).

Requirements:

• Minimum of first degree in Pharmacy i.e. B. Pharm
• Minimum of 1 – 2 years related experience
• Strong client relationship management and development aptitude
• Solid interpersonal/presentation skills
• Proficient in English communication, Prospecting, Analysis skill
• Must be self-motivated, ready to achieve
• Proven ability to work independently
• High level of emotional intelligence
• Previous experience as a Regulatory Affairs Officer/Intern is an added advantage
• Computer literacy