Open to opportunities

KARIMA BEN RADHIA

@karimabenradhia

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Senior Regulatory affairs specialist with 15 years of experience in initial MA submission and life cycle management

Tunisia

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What I'm looking for

I seek a regulatory role where I can lead submissions and lifecycle activities, work collaboratively with cross-functional teams, drive timely approvals, and continue developing expertise across MEA/GCC markets in a structured, quality-focused environment.

I am a regulatory affairs specialist with 15 years of experience reviewing and evaluating pharmaceuticals for human use, focused on initial MA submission, lifecycle management and ensuring compliance across submissions and labeling.

I have led and coordinated regulatory projects for MEA and GCC regions, managing timelines, resource allocation, and client relationships while supporting dossier compilation in CTD/e-CTD formats.

My strengths include change control, preparation and review of labelling and packaging texts, post-marketing activities, and supporting audits and CAPA investigations; I routinely contribute to regulatory intelligence and KPI metrics.

I communicate in Arabic (native), French (fluent) and English (proficient), and I work effectively both independently and as a team lead to deliver regulatory approvals on aggressive timelines.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs senior Specialist

Current

Product Life Group

Feb 2023 - Present (2 years 8 months)

Lead preparation, compilation and submission of regulatory dossiers for MEA region, ensuring timely approvals and compliance with local requirements while coordinating client communications and project timelines.

Regulatory Submissions Project Management Regulatory Intelligence CAPA MS Office

Regulatory Affairs Specialist

Product Life Group

Jan 2022 - Jan 2023 (1 year)

Compiled and supervised regulatory dossiers, provided ongoing regulatory support for GCC submissions, and contributed to KPI tracking and client reporting for marketing authorization and post-authorization activities.

E CTD Management Packaging Text Review KPI Tracking Regulatory Intelligence

Export Regulatory Affairs Specialist

MédiS

Jan 2012 - Dec 2021 (9 years 11 months)

Managed pharmaceutical registration projects for GCC, Middle East and African markets, prepared CTD/e-CTD dossiers and negotiated with regulatory authorities to obtain company registrations and approvals.

Regulatory Affairs CTD Registration Strategy Change Control Market Submissions Project Coordination

Regulatory Affairs Officer

MédiS

Nov 2009 - Nov 2011 (2 years)

Prepared company registration files for Middle East, African and Asian countries and compiled registration dossiers for pharmaceuticals and food supplements to support market access.

Regulatory Submissions International Registrations Documentation Management Market Access Data Evaluation