GSK 2017 Regulatory Affairs Internship

GSK is inviting applications from suitably qualified graduates to apply for a Regulatory Affairs Internship position whose role is to assist the Regulatory Affairs team with the registration of new products, line extensions and new indications. Maintain existing registration dossiers effectively in accordance with the requirement of the MCC and other Southern African countries.  During this time the Graduates, will be exposed to various aspects of Medicine Registration both in S.A. and within OSA.  Scope: This position reports to the Senior Regulatory Affairs Manager

Essential Job Responsibilities:

• Together with the Regulatory Affairs Manager conduct due diligences on new product dossiers.
• Supporting Regulatory Affairs Managers with maintenance of dossiers e.g. variations, PI Amendments
•Following-up on feedback and requirements from the MCC or other OSA regulatory authorities
• With the assistance of the RA Manager, amend and update package inserts and packaging artwork in line with basic text and MCC requirements and ensuring compliance with the approved registration dossier (MRF)
• Maintaining of proper records of all correspondence, applications, etc. relevant to registration
• Assistance with other ad-hoc Regulatory specific projects e.g. labelling compliance, audit requirements

What are the requirements?

Qualifications:  Scientific Degree, B.Sc., Biomedical or related.
Complexity: Be able to interpret and understand Regulatory Guidelines
Knowledge:
• Communication and inter-personal skills.
• Inspire teamwork and motivate others towards goal achievement.
Pressure:
• Ability to work well under pressure
• Ability to meet the deadlines for regulatory specific projects

How to apply?

To apply for this 2017 GSK Regulatory Affairs Graduate Internship Programme CLICK HERE

Closing date: Unspecified