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Regulatory Compliance Pharmacist Manager
Entreprise : Career Directions Ltd (pour le compte d'un client, une entreprise leader dans la distribution pharmaceutique et de produits de santé grand public)
Lieu : Kampala, Ouganda
Type de contrat : Temps plein
Secteur : Pharmaceutique
Salaire : Négociable, entre 5 000 000 et [Click the Apply button below to apply, and Create my CV to build a CV tailored to this offer, professionally] UGX
Date de publication : Il y a 1 semaine
Éligibilité : Ce poste est ouvert uniquement aux ressortissants ougandais.
Présentation du poste
Notre client, une entreprise leader dans la distribution pharmaceutique et de produits de santé grand public, recrute un Regulatory Compliance Pharmacist Manager pour superviser l'ensemble des affaires réglementaires et des activités de conformité en Ouganda. Le candidat retenu veillera à ce que les produits, les opérations et les systèmes qualité de l'organisation soient conformes à toutes les exigences réglementaires applicables, tout en soutenant la croissance de l'entreprise grâce à des enregistrements de produits et des approbations réglementaires en temps opportun.
Ce poste requiert un pharmacien expérimenté, possédant une connaissance approfondie du cadre réglementaire pharmaceutique ougandais et la capacité de diriger des initiatives réglementaires dans un environnement commercial dynamique.
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Diriger la fonction des affaires réglementaires et de la conformité de l'entreprise en Ouganda.
Gérer l'enregistrement, le renouvellement, la variation et la maintenance des licences de produits pharmaceutiques et de santé grand public auprès de la National Drug Authority (NDA) et d'autres organismes de réglementation compétents.
Assurer une conformité continue avec toutes les réglementations applicables en matière de produits pharmaceutiques, de santé et de produits de consommation.
Développer et mettre en œuvre des stratégies réglementaires pour soutenir les lancements de nouveaux produits et l'expansion du marché.
Examiner et approuver la documentation réglementaire, les soumissions et les dossiers produits.
Coordonner les inspections réglementaires, les audits et les réponses aux conclusions réglementaires.
Superviser les processus de libération des produits pour garantir la conformité aux normes réglementaires et de qualité.
Surveiller les changements dans la législation réglementaire et communiquer leur impact à l'entreprise.
Tenir à jour les dossiers réglementaires, les licences, les permis et la documentation de conformité.
Collaborer avec les équipes Assurance Qualité, Supply Chain, Commerciales et Médicales pour garantir la conformité réglementaire dans l'ensemble des opérations.
Établir et maintenir des relations solides avec les autorités réglementaires et les parties prenantes externes.
Fournir des conseils réglementaires aux équipes internes et soutenir la prise de décision interfonctionnelle.
Diriger, encadrer et développer l'équipe des Affaires Réglementaires pour atteindre les objectifs du département.
Soutenir les initiatives réglementaires régionales et contribuer aux projets réglementaires multi-pays le cas échéant.
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Qualifications et expérience
Diplôme de Bachelor en Pharmacie (BPharm) ou équivalent d'une institution reconnue.
Pharmacien inscrit avec une licence d'exercice valide en Ouganda.
Minimum de 8 ans d'expérience en Affaires Réglementaires ou Conformité Réglementaire dans l'industrie pharmaceutique.
Expérience démontrée dans la gestion des enregistrements de produits pharmaceutiques et des soumissions réglementaires auprès de la National Drug Authority (NDA).
Expérience antérieure dans la direction d'une équipe d'affaires réglementaires ou de conformité.
Une expérience de travail dans un environnement pharmaceutique régional ou multi-pays est hautement souhaitable.
Solide compréhension des Bonnes Pratiques de Distribution (BPD), des Bonnes Pratiques de Fabrication (BPF), de la pharmacovigilance et des exigences réglementaires pharmaceutiques.
Maîtrise des applications Microsoft Office et des systèmes de gestion de l'information réglementaire.
Compétences clés
Connaissance approfondie du cadre réglementaire pharmaceutique ougandais.
Solides compétences en leadership et en gestion des personnes.
Excellentes capacités de planification, d'organisation et de gestion de projet.
Haut niveau d'intégrité et souci du détail.
Solides compétences analytiques et de résolution de problèmes.
Excellentes compétences en communication, négociation et gestion des parties prenantes.
Capacité à gérer plusieurs projets réglementaires simultanément tout en respectant des délais stricts.
Capacité à prendre des décisions judicieuses et à gérer les risques.
Expérience préférée
Expérience dans le soutien à la conformité réglementaire pour les produits pharmaceutiques et de santé grand public.
Une exposition aux exigences réglementaires dans plusieurs marchés d'Afrique de l'Est est un atout supplémentaire.
Expérience d'interaction avec les agences de réglementation régionales et les normes réglementaires internationales.
[Click the Apply button below to apply, and Create my CV to build a CV tailored to this offer, professionally]
Regulatory Compliance Pharmacist Manager
Career Directions Ltd
Medical & Pharmaceutical
2 days ago
Easy apply
Kampala
Full Time
Healthcare
USh 5,000,000 - 10,000,000
Our client, a leading pharmaceutical and consumer healthcare distribution company, is seeking to recruit a Regulatory Compliance Pharmacist Manager to oversee all regulatory affairs and compliance activities in Uganda.
Min Qualification:
Bachelors
Expérience
Senior level
Experience Length:
8 years
Language Requirement:
English
Working Hours:
Full Time - 8 to 5
Localisation
Uganda
Profil recherché
Job descriptions & requirements
Job Title: Regulatory Compliance Pharmacist Manager
Location: Kampala, Uganda
Employment Type: Full-Time
Industry: Pharmaceutical
Eligibility: This position is open to Ugandan nationals only.
Role Overview
Our client, a leading pharmaceutical and consumer healthcare distribution company, is seeking to recruit a Regulatory Compliance Pharmacist Manager to oversee all regulatory affairs and compliance activities in Uganda. The successful candidate will ensure that the organization's products, operations, and quality systems comply with all applicable regulatory requirements while supporting business growth through timely product registrations and regulatory approvals.
The role requires an experienced pharmacist with extensive knowledge of Uganda's pharmaceutical regulatory framework and the ability to lead regulatory initiatives across a dynamic business environment.
Key Responsibilities
Lead the company's regulatory affairs and compliance function in Uganda.
Manage the registration, renewal, variation, and maintenance of pharmaceutical and consumer healthcare product licenses with the National Drug Authority (NDA) and other relevant regulatory bodies.
Ensure continuous compliance with all applicable pharmaceutical, healthcare, and consumer product regulations.
Develop and implement regulatory strategies to support new product launches and market expansion.
Missions principales
Review and approve regulatory documentation, submissions, and product dossiers.
Coordinate regulatory inspections, audits, and responses to regulatory findings.
Oversee product release processes to ensure compliance with regulatory and quality standards.
Monitor changes in regulatory legislation and communicate their impact to the business.
Maintain regulatory records, licenses, permits, and compliance documentation.
Collaborate with Quality Assurance, Supply Chain, Commercial, and Medical teams to ensure regulatory compliance across business operations.
Build and maintain strong relationships with regulatory authorities and external stakeholders.
Provide regulatory guidance to internal teams and support cross-functional decision-making.
Lead, mentor, and develop the Regulatory Affairs team to achieve departmental objectives.
Support regional regulatory initiatives and contribute to multi-country regulatory projects where applicable.
Qualifications & Experience
Bachelor's Degree in Pharmacy (BPharm) or equivalent from a recognized institution.
Registered Pharmacist with a valid practicing license in Uganda.
Minimum of 8 years' experience in Regulatory Affairs or Regulatory Compliance within the pharmaceutical industry.
Demonstrated experience managing pharmaceutical product registrations and regulatory submissions with the National Drug Authority (NDA).
Previous experience leading a regulatory affairs or compliance team.
Experience working in a regional or multi-country pharmaceutical environment is highly desirable.
Strong understanding of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), pharmacovigilance, and pharmaceutical regulatory requirements.
Formation / Diplômes
Proficiency in Microsoft Office applications and regulatory information management systems.
Key Competencies
In-depth knowledge of Uganda's pharmaceutical regulatory framework.
Compétences requises
Strong leadership and people management skills.
Excellent planning, organizational, and project management abilities.
High level of integrity and attention to detail.
Strong analytical and problem-solving skills.
Excellent communication, negotiation, and stakeholder management skills.
Ability to manage multiple regulatory projects simultaneously while meeting strict deadlines.
Sound decision-making and risk management capabilities.
Preferred Experience
Experience supporting regulatory compliance for pharmaceutical and consumer healthcare products.
Exposure to regulatory requirements across multiple East African markets is an added advantage.
Experience interacting with regional regulatory agencies and international regulatory standards.
How to Apply:
All applications will be received and reviewed through the BrighterMonday Portal by clicking on the 'Apply Here' section
About Career Directions Ltd
Career Directions Ltd, a recruitment company, is currently looking to fill 5 open positions across sales, quality control & assurance, and customer service & support functions. These roles range from mid to executive level, requiring between 0 to 10 years of experience, offering diverse opportunities for professionals in various stages of their careers.
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Career advice powered by Taf4All
Your safety comes first — read before you go
Taf4All only lists job offers published by third parties. We are not the employer, we do not conduct these recruitments, and we cannot guarantee what happens once you make contact — you deal directly with the person or company behind the offer, at your own risk.
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