Regulatory Project Manager
vor 3 Wochen
ARM is currently collaborating with a prestigious consultancy firm in the life science industry, extending a rare permanent opportunity. This role offers the chance to engage with numerous esteemed clients and diverse projects. Reserved for candidates in the top 10% of the market, it provides unparalleled flexibility, allowing individuals to dictate their workload without constraints on earning potential.
Our Client is seeking a seasoned Regulatory Project Manager to oversee regulatory activities spanning from early development stages to dossier preparation for Marketing Authorisation Applications (MAA) or Biologics License Application/New Drug Application (BLA/NDA) filings. This pivotal role demands a meticulous professional adept at managing multifaceted projects within the regulatory landscape.Responsibilities
Responsibilities:
Manage EU and FDA Marketing Authorisation Application procedures, encompassing the preparation of Module 1 documents, resource allocation, coordination of Mod 2 & 3, tracking Modules 4 & 5, and meticulous project plan preparation and monitoring. Act as a liaison with Regulatory Agencies on behalf of clients throughout the approval process, ensuring seamless interaction before, during, and after approval. Provide invaluable regulatory advice to clients, leveraging your expertise to navigate complex regulatory frameworks effectively. Facilitate Scientific Advice meetings on behalf of clients, including meticulous preparation of supporting documentation. Requirements Master's or PhD in life sciences, medicine, or veterinary medicine. A minimum of 10 years of demonstrable experience in Project Management and Regulatory Affairs, with a comprehensive understanding of FDA and ICH regulations and guidelines. Proficiency in Project Management tools and software, enabling efficient project execution and management. Outstanding communication skills, with a strategic mindset and a solution-oriented approach to challenges. Demonstrated ability to work autonomously and manage multiple tasks concurrently under tight deadlines, showcasing exceptional prioritisation skills and adaptability. Note: Fluency in German and/or additional language proficiency is advantageous. Contact Please apply on Xing, or alternatively you can contact me at or call me on-
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