Mouna Ben Salem

• Perform process mapping of current regulatory affairs processes and gap analysis versus industry best practices
• Propose a series of enhancements and design updated processes with agnostic approach towards chosen RIM system
• Engage with clients during sales meetings, participate in RfP and proposal development for the consultancy offerings within the R&D department
• Develop and/or review SoW aligned with client expectations

Project Delivery Support ( Regulatory Intelligence: Drugs, Medical Devices, Clinical and Pharmacovigilance ) :

• Become an integral member of the delivery team within the Life Sciences Consulting group.
• Act as a point of contact for the customer throughout a project’s lifecycle.
• Act as project manager for regulatory professional services to ensure successful delivery of each assigned project; which includes coordination and tracking.
• Escalate any project risks and delivery issues to the Regulatory Consulting EMEA Manager for action and resolution.
• Support and delivers small pilot projects to validate understanding between the proposed solution and customer needs identified during the sales process.

Business development:
• Support to any received Requests for Information (RFIs) and Requests for Proposals (RFPs).
• Creation of customer-facing materials to support commercial discussions such as samples.

• Compilation, evaluation, and submission of registration dossiers to local and international regulatory agencies (NP, DCP, MRP and CP) of developed products and licensing from other companies.
• Maintenance of approved dossiers.
• Management of documentation and requirements for providing APIs to customers.
• Compilation and Evaluation of DMF.
• Be updated on the regulatory requirements (international legislation, guidelines, and customer practices) and registration procedures in all the company's export markets.
• Regulatory support to various departments of the company.
• Management and development of registration documentation related to manufacturing transfers for customers.
• Writing clear, accessible product labels and patient information leaflet

• Collaboration with team members to develop effective strategies.

• Technical Analysis, Programming, and Testing of Regulatory Affairs software such as Liquent Insight for Publishing, Liquent Insight for Viewing, eCTDmanager, Axway Gateway.
• Daily Support to users of the above-mentioned tools.
• Implementation of a new RIMS system.

• Timely and Correct execution of projects according to defined timelines:
• Preparation of submissions in eCTD and NeeS format to different regions and procedures worldwide including (but not restricted): EU, US, CH...
• Regulatory affairs for submissions in EU (initial application and maintenance activities.)
• Hotline supports for customers of Extedo software
• Submission of dossiers by electronic means (Gateway, CESP..)

• Preparation of baseline sequences (Transitioning to eCTD Format and Resubmission of Non- eCTD dossiers)
• Ensure organizations are in compliance and meeting all of the applicable regulations.