To act as GRP lead for the SA market, to ensure that “Licence to Operate” regulatory activities are being met for all AZ products in accordance with relevant SA legislation, and AZ’s code of “Good Regulatory Practice”.

To effectively manage the SA regulatory team responsibilities and regulatory projects, providing scientific and regulatory expertise and ensuring implementation of best practice in line with current legislation.

Set the strategic regulatory affairs direction for South Africa market working with senior cross-functional team members to ensure the delivery of business-critical regulatory needs.

To effectively manage and control the registration process for specific products within a therapeutic area.

• Obtaining essential marketing authorizations for AstraZeneca products.
• Management and assurance of regulatory compliance of the registration functions.
• Ensure best practice in line with Good Regulatory Practice, current legislation and standards of ethical and professional performance.
• GxP Quality Lead: The Quality Lead is defined as the role in-country that is responsible for ensuring the effective operational implementation of the QMS appropriate to the GxP discipline.
• For GxP Quality Lead are responsible, within their GxP area, for:
• Ensuring the GxP area(s) under their responsibility are run in accordance with external regulations.
• Ensuring appropriate levels of resource to complete GCP, GVP, GRP or GMP/GDP activities appropriately
• Providing/ coordinating training and coaching in the related GxP area for the MC QMS
• Identifying/ agreeing areas of compliance risk and follow-up of any issues
• Ensuring GxP self-assessments in the corresponding GxP area
• Monitoring KPIs in the related GxP area and proposing remedial and improvement actions
• Establishing improvement priorities
• Monitoring internal/external factors such as emerging regulation or shifts in regulatory enforcement
• Identifying trends and communicating identified risks
• Establishing and maintaining business continuity plans in the corresponding GxP area

Essential:

B.Pharm degree. Registered Pharmacist with SAPC.

• English speaking
• Proven regulatory experience in pharmaceutical dossier preparation and submission in SA markets, in an ethical pharmaceutical environment
• Managerial experience
• Computer literacy in MS Office Suite

Desirable:

• Project management experience
• Time management and planning skills
• Excellent written and verbal communication skills
• Strong interpersonal skills with a customer relationship focus
• Uncompromising attention to detail and accuracy
• Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem-solving skills
• Ability to work independently in a high pressurized environment.

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.