Exciting Career Opportunity at Novartis
POSITION: Regulatory Affairs Associate
Summary
- To assist the RA Team in the registration of new pharmaceutical products and the upkeep of registration for approved products to ensure patients can access our offerings.
- To uphold all essential databases (e.g. DRAGON) to achieve a compliance level of up to 95%.
- To execute RA-specific process and quality standards while ensuring that regulatory databases remain current and precise with relevant regulatory parameters during development, registration, and approval (including post-approval commitments and license upkeep).
- To assist the RA team in managing performance and monitoring quality evaluations while swiftly resolving compliance-related challenges.
- To assist the Anglophone West Africa RA Team in the submission and monitoring of labeling and associated tasks for every product.
- Assist the AWA RA Team in lifecycle maintenance tasks and in preparing submissions for post-approval modifications in the AWA Cluster.
- Maintain communication with the Health Authorities to finalize submitted applications and escalate issues when required.
- Assist RA managers by ensuring ongoing communication with internal stakeholders like NTO, CMC, and the AWA RA Team as needed, and consistently offer feedback.
Key Responsibilities
- New Product Submissions: Assist the RA Team by compiling local dossiers for the timely submission of drug registration requests and monitor the application throughout the evaluation process to ensure a positive result.
- Management of registered products: Assist the RA Team in overseeing the registration of presently approved products and submitting timely renewal applications.
- Updating and managing DRAGON along with other pertinent databases to ensure the product information is accurate and current under the oversight of the RA Managers.
- Give feedback from the Health Authority to the RA Team while tracking the submissions sent to the Health Authority.
- Make sure that non-compliance issues are addressed promptly and that the correct channels are involved in a timely way when needed.
- Guarantee adherence to local and international KPIs.
- Establish and nurture positive working relationships with various Novartis functions/departments both locally and globally as needed.
- Assist with RA projects and tasks as directed by RA Managers and RA Specialists.
- Timely communicate any discovered concerns regarding compliance and regulatory insights that impact lifecycle management.
- Manage any extra tasks assigned by the RA Managers.
- Assist the RA Compliance Associate with cluster self-evaluation and audit preparation tasks as needed.
- Assist with label management and ongoing enhancement efforts, evaluate and provide feedback on new regulatory labeling standards.
- Assist in updating country-specific presentations within the AWA cluster.
- Guarantee adherence to local and international KPIs.
- Make certain that non-compliance issues are addressed promptly and that the proper channels are utilized in a timely way when needed.
- Assist with RA projects and tasks as directed by RA Managers and RA Specialists.
- Share any identified compliance and regulatory intelligence issues that impact lifecycle management appropriately.
Key Performance Indicators.
- Prompt registration of new pharmaceutical products and renewal of approved products.
- Prompt submission of post-approval modifications (variations) and subsequent follow-up with the Health Authority for endorsement.
- Guarantee adherence to applicable Health authority standards and laws.
- Tackle compliance-related issues promptly as necessary.
- Precise oversight and upkeep of pertinent regulatory information management systems (e.g., DRAGON, Production Transfer Tool).
- Attain 95% compliance with regulatory deliverables (adherence to applicable databases, training sessions, and similar outcomes)
Requirements
- Education: Bachelor of Pharmacy
- Languages: Proficient in English (essential)
Experiences
- At least 1 year of experience as a Research Assistant
- Effective communication and negotiation abilities. Strong interpersonal abilities.
- Strong comprehension of the regulatory environment in EWA
- Meticulous and orderly
- Strong grasp of CTD dossier structure
How to Apply for this Career Opportunity at Novartis
Closing Date: April 27, 2025
NOTE:
It is important to keep in mind that employers receive many applications for each job posting and will only select the most qualified candidates. Furthermore, NewsNowGh does not have any influence over the decisions made by employers/recruiters. As a result, we cannot guarantee that sending applications will lead to candidates being shortlisted or selected for a particular position.
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