Regulatory Affairs Associate at Novartis International AG

About The Role

• To support the RA Team in registration of new drug products and the maintenance of registration of approved drug products to ensure that patients have access to our products as well as maintain DRAGON and other databases to ensure up to 95% compliance level.
• To implement RA specific process/quality standards as well as ensuring that the regulatory databases are up to date and accurate with regulatory relevant parameters throughout development, registration and approval (including post approval commitments and license maintenance).
• To support the RA team in the performance management and tracking of quality assessments and rapidly addressing compliance related issues
• To support the Anglophone West Africa RA Team in submission and tracking of labelling and related activities for all products

Major Accountabilities

• New Product Registrations: Support the RA Team by preparing local dossiers for submission of drug registration applications in a timely manner and follow up of the application during the evaluation phase to achieve a favorable outcome
• Maintenance of registered products: Support the RA Team in maintaining registration of currently approved products
• Maintaining DRAGON and other relevant databases with up to date and accurate information of the products under the supervision of the RA Managers.
• Relationship with Distributors: With minimum supervision, ensures all registration documents required for importation of products are provided to our distributors to ensure compliance.
• Relationships outside the company: Develop and maintain good working relationships with Health Authority.
• Provide feedback from Health Authority to the RA Team while following up on submissions made to the Health Authority.
• Handle any additional tasks provided by the RA Managers
• Support the RA Compliance Associate in cluster self-assessment and audit readiness activities as required
• Support data consistency management and CCEx activities
• Support the RA Compliance Associate in the process QC by reviewing related records against requirements of SOP and/or regulations to assess the process compliance status. Ensure compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
• Contribute to labeling management and continuous improvement initiatives, review and comment on emerging regulatory labeling guidelines
• Support the maintenance of Country specific presentations in AWA cluster

Role Requirements

• Minimum of bachelor's degree in pharmacy
• Relevant experience in the pharmaceutical industry Proficiency in English
• 1-2 years RA working experience and an understanding of the Nigerian regulatory environment
• Detailed, organized and good interpersonal skills