Regulatory Affairs Assistant at Sanofi

JOB PURPOSE:

Assists the Regulatory Affairs Pharmacists/Senior Regulatory Affairs Pharmacist/Drug Regulatory Affairs Manager to register products in the shortest possible time and assists in the maintenance of dossiers. Will be required to ensure coversion of old format dossiers to CTD e-submission format. Dossier maintenance and communication record history will be a key requirement for this role.
 

KEY ACCOUNTABILITIES:

• To provide appropriate dossier support to the Regulatory Affairs Pharmacists/Senior Regulatory Affairs Pharmacist/Drug Regulatory Affairs Manager
• Completes minor amendments to the dossiers.
• To assist in the typing of documents for the Regulatory Affairs Pharmacists/Senior Regulatory Affairs Pharmacist/Drug Regulatory Affairs Manager
• To provide appropriate dossier administration to the Regulatory Affairs Pharmacists/Senior Regulatory Affairs Pharmacist/Drug Regulatory Affairs Manager
• Ensures that the necessary copies of the dossier are made for the Health authorities
• To keep record of approved printed packaging components and change control.
• Understand and execute the latest requirements e-submission and e-CTD requirements to ensure dossier maintenance and updates.
• Support the regulatory affairs portfolio managers with submission of variations via the online portal.
• Submisison of SMF updates, Licence application updates to SAHPRA, DOH, SAPC as required.
   

JOB-HOLDER ENTRY REQUIREMENTS :
Education:

• Std 10/ Form 12 with Mathematics

Experience & Knowledge:

• Secretary
• Ideally have regulatory experience
• Have a systematic approach
• Work with supervision

Core Competencies:

• Knowledge
• Computer literate

Behaviour

• Flexibility in terms of priorities
• Good communication skills
• Team player
• Shows initiative