· Regulatory maintenance with minimum supervision, organise and take a key role in Health Authority interactions, evaluate, perform risk assessment and mitigation where necessary (under supervision of the RA Cluster Head) to achieve a successful outcome.
· Regulatory compliance – Implements accurately and timely measures aiming at the maintenance and regulatory compliance of the company assigned registered
· product range. Is accountable for assigned portfolio to comply with relevant of the company standards (DRAGON, NovaRim, CCEx, SUBWAY, COSTA…) and policies as well as all relevant legal and regulatory requirements. In addition, undergoes suitably qualifications and assigned training to fulfil internal and external compliance standards
· Provide support as needed in preparation and coordination of presentations and relevant regional overviews for portfolio.
· License maintenance activities: ensure timely availability of key elements to support successful licenses in the markets and optimal tracking. Eg renewals, CMC variations. PTs, etc..
· Manage and Track regulatory databases (e.g. Health Authority submissions and approvals in FWCA countries, CDS (triggered by safety issues), RMP updates) and prepare metric reporting according to Regional processes and KPIs
· Provide operational support for obtaining up-to-date Regulatory Intelligence and other regulatory support Information
· Ensures quality and compliance of regulatory activities in FWCA by adhering to corporate processes, business guidance, SOPs.
· Responsible for implementing RA SOPs, specific process/quality standards in FWCA.
· Support address audit findings, and partners with RA CO Manager, CO QA to mprove efficiency and functionality, and maintain CO compliance.
· Oversight of out-of-compliance cases in FWCA cluster, tracking of cases, identification of root causes and solutions, rapid implementation, and regular report to Management
· Relationships within and outside the company - Develop and maintain good working relationships with other departments both locally and with Head Office and with health authority and industry bodies.
· Ensure all business activities comply with relevant Acts, legal demands and ethical standards.
Impact on the organisation:
Contributes to maintenance of products and to consistent alignment of global development strategy
with the commercial priorities in the country. Ability to achieve timely submissions/ approvals and to adhere to regulatory requirements. Directly impacts time to market of products. Ensures regulatory compliance of assigned portfolio at all times.
· A minimum of one (01) year experience in regulatory affairs
· Fluent in English (oral and writing)
· Dealing with License maintenance projects and issues.
· Tracked successful interactions with Health Authorities is advantageous.
· Strong self-organising and analytical skills
· Good understanding of regulations in assigned countries
· Good communication and negotiation skills
· Collaborative mindset
· Able to work with strict deadlines.
· Shows cultural awareness
Applications are received solely through http://www.emplois.groupe-cible.com
DEADLINE: 18th March 2021 at 12 :00 AM