Regulatory Affairs Specialist (Sub Saharan Africa) at Stresert Services Limited

Our client is a multinational Pharmaceutical organization. They seek the services of a Regulatory Affairs Specialist for a 2 years contract engagement.

Department: RA (Global Drugs Development) GDD

Reports to:  RA Head

 – 2 YEARS CONTRACT

Job Purpose

• Support the region (Sub Saharan Africa - SSA) with lifecycle maintenance activities
• Coordinate submission of post-approval changes including variations and renewals for the region (SSA)
• Coordinate update of (Chemistry Manufacturing & Controls - CMC) database when there are changes in country regulations and/or requirements
• Maintain all necessary databases (e.g. DRAGON) to ensure regulatory compliance at all time.
• Maintain open communication with the different stakeholders and regularly provide information when required.

Major Accountabilities

• Ensure the RA CMC database for the different countries in the region is up to date
• Evaluate post-approval changes for impact on product supply and communicate to stakeholders accordingly
• Ensure submission of post-approval changes such as production transfers, MAT and pack size extension are done on-time and approvals received early enough to ensure smooth implementation
• Ensure that submissions for license renewal are done in good time before license expiry so as to achieve early approval
• Support the update local/Regional Working Practices or SOPs when required.
• Ensure adherence to Global and local/regional processes.
• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary
• Ensure compliance to global and local KPIs.
• Develop and maintain good working relationships with other company functions/departments both locally and globally, as well as with health authorities as required

Key Performance Indicators

• Ensure compliance with relevant Health Authority guidelines and regulations
• Ensure all post-approval changes are submitted on time and follow up for approval
• Meet product re-registration due dates and escalate possible adverse impact due to loss of license accordingly
• Accurate maintenance of relevant regulatory information management system
• Achieve Regulatory compliance deliverables as per global targets
• Address issues related to compliance with urgency with escalations as appropriate
• Share emerging regulatory intelligence with RA Heads

ROLE PROFILE

Education:          B. Pharm             

Languages:         Fluent in English (mandatory)

Experience:        At least 4-5 years RA experience

• Good communication and negotiation skills
• Good knowledge of CTD dossier format
• Detail-oriented and organized
• Good inter-personal skills

Application:

Candidates with a similar background who do not hold permanent employment should forward CVs to ‘recruitment@stresertservices.com’ using ‘RAS-2YR’ as the subject of mail before 1st March, 2020. Applicants without the aforementioned background and experience need not apply.