To effectively manage and control all registration processes defined by allocated countries or specific products, including:

• Obtaining essential marketing authorizations for AstraZeneca products and maintaining existing product licenses.

• Management and assurance of regulatory compliance of the regulatory functions.

• Ensure best practice in line with Good Regulatory Practice, current legislation and standards of ethical and professional performance.

• Implement registration plan and business support for allocated products

• Implement GRP standards in the FSA markets in line with International Procedure 1-P56-cv-X “Good Regulatory Practice in AstraZeneca” that support License to Operate across the Regulatory Value Chain.

• Ensure that the regulatory processes for allocated markets/products are performed timeously in line with GRP.

Marketing Authorization Applications:

• Submit Marketing Authorization Applications to Health Authorities according to local guidelines and GRP, in the shortest possible time based on business priorities. 

Licence maintenance:

• Ensure all post-approval product maintenance activities including CMC variations, package insert safety updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments are submitted and approved.

• Ensure all Licence Renewals are submitted on time prior to licence expiry, or in accordance with the planned submission date at stipulated in the Global database.

Submissions compilation and dispatch:

• Complete due diligence of registration documents/dossiers

• Obtain relevant information from key global RA and resolve queries to ensure delivery of submissions within agreed timelines.

Labeling & Artwork Management:

• Ensure labeling and artworks are effectively managed through the AstraZeneca Global Labeling Business Process using the GAZELLE system.

Health Authority interactions:

• All communication with Health Authorities regarding submissions, product registration or maintenance throughout the life-cycle of the product is managed effectively via the FSA in-market contact/distributor

Essential:

• B.Pharm / Scientific Degree
• Registered Pharmacist
• French - Speaking
• Proven regulatory experience in pharmaceutical dossier preparation and submission in French-Speaking Africa or Sub-Saharan Africa markets, in an ethical pharmaceutical environment
• Excellent written and verbal communication skills
• Uncompromising attention to detail and accuracy
• Ability to work independently in a high pressurized environment
• Computer literacy in MS Office Suite

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.