A trademark recruitment portal of 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
Job Location: Lagos
· 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.
· 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.
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
Candidates with a similar background who do not hold permanent employment should forward CVs to ‘firstname.lastname@example.org’ using ‘RAS-2YR’ as the subject of mail before 1st March, 2020. Applicants without the aforementioned background and experience need not apply.