Hiring: Director, Regulatory Affairs - CMC/Biologics Company: ICON plc Location: Blue Bell, PA Job Posted Time: 2026-09-10 10:34:11 Employment Type: Remote About the job Experience: •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. •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. Required Skills: •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. •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. •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. Qualifications: •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. •Certification in regulatory affairs (RAC) or post-secondary institution beneficial. Compensation: •Flexible work environment (work from home / hybrid options) •A range of health insurance offerings to suit you and your family’s needs •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!