Director, Regulatory Affairs - CMC

Director, Regulatory Affairs - CMC ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. 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, biologics with regulatory experience in the global environment (e.g. US, EU, Canada). Technical development, testing and manufacturing of wide range of dosage forms Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance. Experience supporting business development activities and people management an asset. Certification in regulatory affairs (RAC) or post-secondary institution beneficial. #LI-SB4 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply