Job Opportunities at GlaxoSmithKline South Africa (Pty) Ltd.

Job description

Qualifications

Basic qualifications:

• Matric Certificate
• Minimum 2 years experience in Regulatory Affairs as an assistant within the Pharmaceutical Industry
• Basic Scientific and medical knowledge

Knowledge

• Knowledge and experience of Regulatory Affairs and CTD dossier format
• Ability to prioritise and work on tight deadlines
• Detail orientated and organised
• Advanced typing skills
• Analytical and interpretative skills
• Excellent computer knowledge – proficient in MS Word, Excel

Complexity

• Organisation skills
• Computer Literacy
• Ability to prioritise and pay attention to details
• Ensure and maintain a high standard of confidentiality.
• Independent Thinking
• Display ability of independent thinking in matters relating to administrative role.

Details

Preferred qualifications:

Purpose

Job Purpose:

• To provide Technical support to the Regulatory Affairs Department
• To ensure consistent maintenance of documentation systems and processes

Scope

Assist with the Technical aspects of the dossiers. This includes, maintaining the compliance of the of the dossiers that are registered with the Regulatory Authority for both South and Southern African countries
Provide administration assistance to Regulatory Affairs Department

Essential Job Responsibilities

• All administrative functions for the Regulatory Affairs department:
• Management of all filing, copying and preparation of new product submissions and variations under the direct supervision of the Regulatory Affairs Manager
• Filing of all MoH correspondence received from MoH and submitted to MoH
• Other
• Setting up of SSA meetings for the team, ensure minutes and agenda are sent out prior to meeting and ensure minutes are captured and agreed prior to dissemination to team
• Complete responsibility for Product Dossier Management both hard copies and soft copies (RA Manager is accountable)
• Management of Product Information Files and Medical Device Technical Files
• Payments of applicable fees to MoH, other regulatory bodies and associations
• Management of OPAL events, variations and approvals for SSA

Responsibility

• Ensure accurate record keeping within the regulatory department
• Checking that the location of registration documentations and dossiers copies are recorded and maintained and controlled
• Ensure that the allocated projects for Regulatory are completed within the allocated timeframe

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.

go to method of application »

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.