GRCY-0, Senior Reg Affairs Associate
vor 1 Woche
Join to apply for the Senior Regulatory Affairs Associate role at Merck Healthcare. We are seeking a highly motivated and experienced Senior Regulatory Affairs Associate to lead end‑to‑end regulatory strategy and activities for our growing portfolio of pharmaceutical products. What You Will Do As a Senior Regulatory Affairs Associate you will be responsible for managing and driving end‑to‑end regulatory submissions and approvals for pharmaceutical products. You will play a pivotal role in leading the strategy and execution of regulatory activities that enable timely registrations, optimal labelling and seamless lifecycle management. Main Responsibilities Manage pre‑submission activities, Category 1 applications to the TGA and Medsafe. Perform dossier analysis, lead the strategy and execution of regulatory activities that enable timely registrations, optimal labelling and lifecycle management. Collaborate with local cross‑functional, regional and global teams to facilitate successful registration, commercialisation and life cycle management of our products. Ensure compliance as per local regulations. Liaise with the TGA and Medsafe as required. Who You Are Bachelor’s degree in life sciences, pharmacy, or a related field, with a minimum of 5 years of experience in Regulatory Affairs. Experience in leading the dossier and regulatory strategy for applications to the TGA and Medsafe. A proven track record of successful regulatory approvals, especially in rare tumours/diseases, including Orphan Drug Designation applications. Experience in leading interactions with the TGA and Medsafe that result in successful regulatory outcomes. Experience in drug development and clinical trial application or notification is highly regarded. In‑depth knowledge of the Australian regulatory requirements for drug development and registration. Strong analytical and problem‑solving skills. Ability to work effectively and collaboratively with local cross‑functional, regional and global teams. How To Apply If you are passionate about making a difference in the lives of patients with rare diseases, we invite you to apply by sending your resume and cover letter to the link provided below. Benefits Work with a purpose‑driven global healthcare company. Make a real impact on patients with high unmet medical needs. Inclusive and collaborative company culture. Location: Sydney | Employment Type: Full‑Time | Company: Merck Healthcare #J-18808-Ljbffr
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GRCY-0, Senior Reg Affairs Associate
vor 4 Wochen
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