RA Associate at Novartis International AG

Job ID: 222009BR
Location: Lagos
Division: SANDOZ
Business Unit: Commercial Ops SZ
Functional Area: Research & Development

Job Description    

• New Product Registrations: Prepares and submits documentation for application of drug registration in a timely manner and monitoring of the application during the evaluation phase to achieve a favourable outcome within agreed timeframes
• Maintenance of registered products: Support the DRA Manager, Sandoz in maintaining registration of currently approved products and timely submission of documentation for renewal of registration.
• Prepares, submits and monitors variation packages to the health authority and ensures timely approval
• Prepares & submits CDS update and PSUR to the health authority and ensures safety update is implemented if required
• Prepares text master and final artwork master in accordance with local labelling regulations and Sandoz internal requirement
• Ensures the implementation of Company corporate Quality Standards in the RO to be compliant with Novartis Quality standards/Sandoz Standards.
• Ensures full QA support for all QA related activities.
• Assist in ensuring that all aspects of the handling and distribution of pharmaceutical products at the site/in the country and all other QA related activities comply with the requirements of the Novartis Quality Manuals (QM), Sandoz GOPs and internal company SOPs
• Ensures implementation of relevant Sandoz d.d. SOP to the RO organisation
• Ensures that compliance is maintained for Quality System and all Standard Operating procedures (SOPs) are in place for all GXP related activities
• Assists in ensuring adequate escalation process up to the management according to escalation management
• Maintains knowledge of local and international regulatory and legislative requirements and trends to ensure technical support on all quality related aspects to the RO
• Ensures all product specific annexes and QA agreement with each sites are updated and approved
• Assists in ensuring that all activities related to complaints, market action/recalls are performed in accordance with the relevant QM and are in compliance with the local regulations and Sandoz standards
• In case of any local third party coordination of the following activities with Sandoz d.d. responsible person: Audit and Quality Agreements with 3rd parties. Ensures coordination of third party activities (re-packaging, re-labelling , storage and/or distribution in way that all activities on 3rd party site are in compliance with Sandoz standards

Minimum Requirements    

• Bachelors Degree in Pharmacy English 2 - 5 years experience in Regulatory Affairs or a similar role