Experienced Regulatory Affairs Professional - Lifecycle Submissions (Emerging Markets)

Casablanca, Casablanca-Settat, Morocco

Décryptage du poste par Postule AI

Résumé du rôle

Experienced Regulatory Affairs Professional role at Johnson & Johnson supporting pharmaceutical lifecycle submissions across emerging markets in the MAFSA region. This hybrid position requires 3+ years of regulatory affairs experience and fluency in French, English, and Arabic. The role involves coordinating end-to-end lifecycle management, preparing regulatory submissions, managing health authority approvals, and driving process improvements within a collaborative regional team.

Exigences clés (estimation)

Coordinate end-to-end lifecycle management procedures and ensure timely submissions with database updates
Prepare high-quality submission-ready documents and dossiers for health authority submissions
Propose strategies and timelines for National Procedures and liaise with regional regulatory teams
Process Health Authority approvals and initiate post-approval activities promptly
Conduct risk assessments, establish mitigation processes, and monitor completion of lifecycle activities
Contribute to process improvement initiatives and implementation of new regional requirements and systems

Compétences

Pharmaceutical regulatory affairs expertise with 3+ years experienceFluency in French, English, and Arabic languagesLifecycle management and regulatory submissions knowledgeRisk assessment and mitigation process developmentStakeholder coordination and cross-functional collaborationDatabase management and documentation skills

Niveau estimé

This role requires 3+ years of pharmaceutical regulatory affairs experience, positioning it at a mid-to-senior level. Candidates should demonstrate established expertise in regulatory submissions and lifecycle management with the ability to work independently under moderate supervision.

Attributs détectés par l’IA (si absents de l’offre)

Type de poste: full-time
Mode de travail: Hybride
Fonction: Juridique
Secteur: Pharmaceutique
Langues: Français, Anglais, Arabe

Cette analyse a été générée automatiquement par Postule AI à partir de l'offre.

About the Role

Join Johnson & Johnson's Cross-Regional Operations & Strategic Support (C-ROSS) team as an Experienced Regulatory Affairs Professional specializing in lifecycle submissions. This hybrid position is based in Casablanca, Morocco, and supports the MAFSA region including Algeria, Morocco, Tunisia, Benin, Burkina Faso, Cameroon, Chad, Comoros, Congo, Gabon, Guinea, Ivory Coast, Madagascar, Mali, Mauritania, Mauritius Island, Niger, RCA, Senegal, and Togo.

Main Responsibilities

Coordinate end-to-end lifecycle management procedures, ensuring timely submissions and implementation of changes in applicable databases and artwork
Prepare submission-ready documents and dossiers, ensuring high-quality submissions to health authorities
Propose strategies and timelines for National Procedures (NP) to Local Operation Companies (LOC) and liaise with Regional Regulatory Responsible (RRR) teams
Process Health Authority approvals and initiate post-approval activities promptly
Conduct routine risk assessments and establish mitigation processes within the regulatory function
Monitor lifecycle management activities from end-to-end perspective, proactively escalating issues and contributing to process improvement initiatives

Key Requirements

3+ years of experience in pharmaceutical regulatory affairs
Fluency in French, English, and Arabic
Experience with regulatory activities and lifecycle management procedures
Ability to work under moderate supervision as an established individual contributor

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. We are committed to providing an inclusive work environment where each person is valued for their individual contributions and merit.

Cette description d'emploi a pu être reformatée par Postule pour améliorer sa lisibilité et sa présentation. Le contenu et les informations restent fidèles à l'offre d'emploi originale. .