Associate Director, Regulatory Affairs Select Pharma

il y a 3 jours


Grenoble, France Select Pharma Limited Temps plein

Our client are at the forefront of drug delivery and injection technologies. They provide innovative solutions to pharmaceutical and biotechnology companies worldwide, with billions of devices manufactured annually across their seven international manufacturing facilities.In this strategic role based in Grenoble you will lead regulatory initiatives for existing products on the market, while ensuring outstanding customer support. You will be a key leader in managing regulatory files, international expansion, compliance, and coordinating cross‑functional teams: Regulatory Affairs, R&D, and Quality.Responsibilities:To build, mentor and develop a high‑performing team, focused on solutions and cultural transformation.Manage all regulatory activities for marketed products to ensure their compliance and customer support.Taking responsibility for actions related to customer excellence: regional support, leveraging customer feedback and creating value for the company.Supervise the review of promotional materials and ensure their compliance with regulatory requirements.Train cross‑functional teams on European and American (FDA) requirements applicable to our pharmaceutical systems and those of our clients.To ensure regulatory registrations with the relevant authorities and their updating. To prepare teams for interactions and negotiations with regulatory agencies.Your profile:Experienced Regulatory Affairs team manager with strong strategic and operational skills.Solid experience in the pharmaceutical, medical device and ideally combined product (drug‑device) industries.Proficiency in regulatory submissions and communication with relevant authorities.In‑depth knowledge of US regulations (FDA), GxP and the Quality System Regulation.Comfortable in matrix and multicultural environments.An inspiring and motivating leader, focused on talent development and continuous improvement.Proven skills in communication and project management.Salary range for the position: €90,000 – €110,000 base salary + bonus + package #J-18808-Ljbffr



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