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Hybrid in EU: Regulatory Ops Contractor (235739) - Black Diamond Networks Hybrid in EU: Regulatory Ops Contractor (235739) Partager Share on LinkedIn Share on X (Twitter) Share on Facebook Share on Email Start Date • November 1st • Dublin, Ireland Duration • 12-Month Contract Schedule • hybrid/ 2 days on site 3 days remote Job Summary • Our client is seeking an experienced Regulatory Operations Contractor for a 12-month contract. This role will be pivotal in managing regulatory ops group supporting a small team for regenerative medicine products, drafting and reviewing SOPs and ensuring the accuracy and compliance of regulatory artwork. Responsibilities • Draft, review, and update Standard Operating Procedures (SOPs) related to regulatory operations • Collaborate with cross-functional teams to ensure SOPs reflect current regulatory requirements and operational practices. • Maintain version control and documentation for all SOPs, ensuring they are up to date • Track submission timelines and ensure that deadlines are met, communicating any potential risks • Review product artwork and labeling (including packaging, inserts, and promotional materials) • Maintain regulatory submission archives • Regulatory Compliance and Documentation • Review and ensure accuracy of all submission-ready documents • Identify areas for improving submission processes, SOP management, and artwork review workflows. Qualifications • Bachelor’s degree in Life Sciences • 5+ years of experience in regulatory operations • Strong experience with SOP writing and review • Experience reviewing regulatory artwork, labeling, and product packaging to ensure compliance with global standards. • Proficiency in eCTD publishing software and knowledge of global regulatory submission requirements • Familiarity with RIMS • Irish regulatory affairs experience Hybrid in Dublin, Ireland: Regulatory Ops Contractor (235739) #LI-Hybrid Postuler À propos de Black Diamond Networks Les réseaux Black Diamond permettent aux talents de s’épanouir. Nous déployons des consultants hautement qualifiés pour soutenir la qualité, la conformité et l’innovation dans les industries réglementées et au-delà. Le modèle de livraison de Black Diamond est conçu pour être rapide et précis, grâce à une communauté cultivée d’experts en sciences de la vie, en ingénierie et en technologie. Augmentez vos attentes en matière de solutions dynamiques. Black Diamond Networks est un employeur qui souscrit au principe de l’égalité des chances et de l’action positive. Tous les candidats qualifiés seront pris en considération pour un emploi sans distinction de race, de couleur, de religion, de sexe, de grossesse, d’orientation sexuelle, d’identité de genre, d’origine nationale, d’âge, de statut d’ancien combattant protégé ou de statut de handicapé. Date de début ASAP Postuler Ce poste n’accepte plus de candidatures.