_At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies._ **Job Overview** As an experienced individual contributor within IQVIA Biotech’s Regulatory Affairs team, you’ll operate under limited supervision to drive clinical trial regulatory strategy and delivery across complex, multi‑stakeholder projects. You’ll lead cross‑functional regulatory workstreams, prepare and review clinical trial submission materials, and act as a clinical trial regulatory subject‑matter expert (SME) throughout the clinical trial lifecycle. You’ll build trusted relationships with sponsors, present at bid defenses, manage scope and budget for assigned projects, and contribute to team capability by reviewing SOPs and delivering targeted training. This role reports into Regulatory Affairs leadership and collaborates closely with study start-up, clinical monitoring, and project management colleagues to keep clinical trial regulatory filings on track and inspection‑ready. **Key Responsibilities** + Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing. + Draft, review, and quality‑check clinical trial regulatory core study documentation at global and country level . + Engage directly with clients to clarify clinical trial regulatory pathways, share lessons learned, and address feedback. + Engage with Competent Authorities in countries across multiple regions, as part of the clinical trial regulatory strategy for complex global studies + Monitor scope, deliverables, timelines, and budget; proactively mitigate risks and escalate issues as needed. + Provide guidance and feedback to junior colleagues; support training and continuous improvement initiatives. + Contribute to internal SOP reviews and present regulatory processes at full‑service bid defenses. + Perform additional tasks assigned by Regulatory management to meet program goals. **Qualifications** + Bachelor’s or Master’s degree in Life Sciences or related discipline. + 3–4 years of relevant clinical trial regulatory experience within CRO or biotech/pharma. + Strong understanding of the R&D continuum (CMC, preclinical, clinical) and applicable laws, guidelines, and agency expectations for clinical trials. + Demonstrated expertise in at least one clinical trial regulatory domain (e.g., CMC, labeling). + Experience with clinical trial regulatory submission platforms and pathways, including but not limited to, EU CTR, Health Canada, US FDA IND submissions and/or systems in other regions such as LATAM or APAC. Biotech therapy area exposure welcomed. + Proficiency with Microsoft Office and regulatory publishing tools (e.g., eCTD systems); meticulous document management skills. + Excellent written and verbal communication, organization, and stakeholder‑management abilities. + Proven ability to manage multiple projects; work in a fast-paced environment with competing priorities; and view obstacles as challenges to be handled with ease and grace; follow SOPs consistently, and exercise sound judgment on discrete tasks. + Problem‑solving mindset with adaptability in fast‑changing environments; self‑motivated and collaborative. **Why IQVIA Biotech** Join a nimble, therapeutically aligned team that partners closely with biotech sponsors to bring breakthrough treatments to patients faster. If you’re ready to lead with rigor, collaborate with purpose, and grow your regulatory impact, we’d love to hear from you. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled