Director, Regulatory Affairs - CMC/Biologics

Director, Regulatory Affairs - CMC/Biologics ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. Director, Regulatory Affairs CMC Location The position may be remote based across the US, or East Coast preferred The Role As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group. The department is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance. We are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience. Responsibilities Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues, and clients providing advice Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams. Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise. Enthusiastically monitors for new regulatory requirements and shares key findings. Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed. Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports Serve as US Agent for client submissions and act as interface with local agency and sponsor Support right from preclinical to post approval activities for client submissions. Education/Experience Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field. Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial. Relevant experience i.e. pharmaceutical,…