CMC Regulatory Specialist
hace 14 horas
Please note this position can be located in our offices in Barcelona with 2 days on site. Asegúrese de leer detenidamente la información sobre esta oportunidad antes de presentar su candidatura.G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.We now have an exciting opportunity for Regulatory professionals to provide expert guidance and support across a variety of biological products. You’d be joining our international team of experienced Regulatory professionals who manage multiple global projects for a wide variety of clients – from giant pharma to niche biotechs.A day in the life of one of our consultants may be varied and unpredictable – this opportunity is ideal for someone who thrives on challenges, enjoys client interaction, and guiding client programs through complex regulatory strategies.Key ResponsibilitiesPlan and prepare strategies for post-approval activities like variations, renewals, market expansions, and annual reports.Evaluate change controls and provide regulatory insights on quality changes in production and quality control.Review study reports (process validation, stability studies, analytical method validation) from quality control and production to ensure everything meets regulatory standards.Work with teams across manufacturing, supply chain, quality control, quality assurance, and other regulatory departments to coordinate submission preparation.Write or review submission content to make sure it aligns with regulatory requirements (for variations and health authority questions).Identify, elevate, and manage risks related to regulatory procedures and activities.QualificationsStrong understanding of CMC and post-approval regulatory requirements.Knowledge of regulatory processes, systems, and guidelines (quality control, stability, process validation, comparability studies).Excellent written and spoken English.Proficiency in a local language (French, Italian, or German depending on location).Understanding of biological processes and qualification/validation principles.Desired AttributesGood at managing time to meet deadlines.Clear communicator, especially in a multicultural and multidisciplinary setting.Strong writing and analytical skills, with a keen attention to detail.Creative, critical thinker.Team player who is flexible, well‑organized, and accountable.ExperienceExperience in regulatory affairs (especially in technical/CMC/quality) within the pharmaceutical industry.Experience writing CMC (technical) sections for regulatory documents (registration files or variations).Experience in validation, Quality Assurance, or production, with experience preparing regulatory documents.Experience working with Biological products mandatory for the role.Education & Other RequirementsUniversity degree (preferably in Life Sciences) or equivalent experience.Proficient in Word, PowerPoint, Excel; familiarity with Veeva Vault is a plus.Fluent in English and depending on location, French, German, or Italian.#J-18808-Ljbffr
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