Regulatory Affairs Graduate at GlaxoSmithKline (GSK)

Job description

Qualifications

Basic 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

Details

Preferred qualifications:

Job Purpose

• 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

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Preference will be given to candidates in line with the GSK SA and GSK Consumer Healthcare Equity Plan.