RA GDD Compliance Associate at Novartis International AG

Job ID: 344799BR
Employment Type: Regular
Business Unit: REG Affairs GDD
Division: Global Drug Development
Functional Area: Research & Development

Job Description

• The PIE/Compliance and labelling associate is responsible for implementing 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).
• Partners with other functions in the performance management and tracking of quality assessments and rapidly addressing compliance related issues
• Ensures compliance to all trainings roll out (mandatory and expected) for the EWA Reg team and ensures new joiners are supported during their onboarding process.
• Supports the English West Africa RA Team in submission and tracking of labelling and related activities for all products.

Responsibilities
Compliance:

• Lead data consistency management and CCEx activities
• Work with the regional Process Improvement Excellence team regional to develop country annual process compliance check plan, by identifying processes with high risk.
• Lead Cluster Self-assessment and audit readiness activities
• Conduct process QC by reviewing related records against requirements of SOP and/or regulations to assess the process compliance status. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
• Complete process QC report; provide feedback on process compliance and enhance process implementation to RA Head
• Perform trend analysis of identified quality and process compliance observations and communicate to the RA head remediation plan
• Provide advice on CAPA generation for QC/audit/inspection, and follow up the action owner to ensure CAPA completeness.
• Lead quality improvement initiatives.
• Provide support on team management of GDP and archiving activities. Ensures a controlled documentation system (including paper and electronic records retention processes)
• Drive development of working models to support enhanced compliance status in English West Africa Cluster
• Supports training of all associates in EWA and ensures compliance

Labelling:

• Serves as the labeling lead for all labeling related activities for all products and development projects in English West Africa
• Contribute to labeling management and continuous improvement initiatives, review and comment on emerging regulatory labeling guidelines
• Responsible for the maintenance of Country specific presentations in English West Africa cluster
• Performs Artwork inspection/assessment to ensure compliance with current regulations/guidelines in English West Africa cluster

Commitment to Diversity & Inclusion:

• Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Job Requirements

• Education (minimum / desirable): B. Pharm or B.Sc in Life Sciences
• Experience: 2-3 years RA experience
• Languages: Fluent in English (mandatory)
• Good communication and negotiation skills. Good inter-personal skills.