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Regulatory Affairs Manager

2 mesi fa


Monza, Italia Scientasearch Limited A tempo pieno

JOB DESCRIPTION The Regulatory Affairs Manager will be responsible for overseeing the regulatory submissions and process for products, from development to post-market approval.
Responsibilities:Prepare, review, and submit regulatory documents (eCTD Modules 1 and 3) ensuring accuracy and compliance.Respond to regulatory agency inquiries and monitor timelines for licence variations, transfers and renewals.Participate in meetings with regulatory agencies and manufacturers, providing guidance.Track regulatory submissions and approvals, and review packaging artwork for compliance.Prepare Summary of Product Characteristics, Patient Information Leaflets, and labelling per QRD format.Collaborate with RD, Quality, and Marketing teams to meet regulatory requirements.Maintain electronic regulatory archives and stay updated on relevant legislation and guidelines.Experience Profile:Master's degree in pharmaceutics, healthcare, life sciences, or related fields preferred.5+ years in regulatory affairs within the pharma industry, with experience in European submissions (MRP/DCP)Knowledge and experience in pharmaceutical development, process validation, and regulatory compliance documentation.Fluent in English with strong planning, time management, and communication skills.
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