Regulatory Affairs Specialist

Keys Recruiters · Cairo, Egypt · Posted 2026-05-05

ob Title: Products Registration Senior SpecialistEmployment Type: Full-timeJob Overview:We are seeking a detail-oriented and highly organized Products Registration Senior Specialist to join our team. The ideal candidate will be responsible for managing product registration activities, ensuring regulatory compliance, and coordinating with internal and external stakeholders to ensure timely submissions and approvals.Key Responsibilities:Prepare, review, and manage regulatory dossiers for product registrationsVerify and validate scientific and technical documentation for compliance accuracyEnsure proper documentation control, filing, and archiving of regulatory recordsInterpret and apply relevant regulatory guidelines to ensure full complianceCoordinate with cross-functional teams including Regulatory, Private Label, and SuppliersTrack, monitor, and report on registration status and submission timelinesEnsure timely execution of all regulatory submissions in line with deadlinesCommunicate effectively with suppliers, internal teams, and regulatory authoritiesSupport inquiries by preparing accurate responses and documentationIdentify and resolve regulatory challenges with compliant and practical solutionsMaintain strong attention to detail and ownership of assigned deliverablesStay updated with evolving regulatory requirements and industry standardsRequirements:Education & Experience:Bachelor’s degree in Pharmacy (required)1–3 years of experience in regulatory affairs (preferred)Regulatory certification is a plusTechnical Skills:Strong experience in data verification and scientific document reviewKnowledge of dossier preparation and regulatory documentation processesGood understanding of document control and archiving systemsProficiency in MS Office and Adobe ReaderAbility to quickly adapt to new digital tools and systemsCoordination & Management Skills:Ability to coordinate across multiple teams and stakeholdersStrong time management and ability to meet strict deadlinesExperience tracking project progress and reporting updatesPersonal Skills:Strong communication skills (written and verbal)Analytical thinking and problem-solving abilitiesHigh attention to detail and strong organizational skillsProactive attitude with a continuous learning mindsetPreferred Qualifications:Knowledge of SFDA or SABER registration systems (cosmetics, food supplements, medical devices)Experience with regulatory frameworks in different marketsPrior experience in preparing and submitting regulatory dossiers

Apply for this role