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 regulatory strategy and delivery across complex, multi‑stakeholder projects. You’ll lead cross‑functional regulatory workstreams, prepare and review submission materials, and act as a 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 clinical, CMC, and quality colleagues to keep programs on track and inspection‑ready.

Key Responsibilities

• Serve as Regulatory Team Lead on complex studies, including oversight of technical writing and submission publishing.
• Draft, review, and quality‑check regulatory documentation in your area of expertise (e.g., CTD/eCTD modules, variations, renewals).
• Engage directly with clients to clarify regulatory pathways, share lessons learned, and address feedback.
• 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 regulatory experience within biotech/pharma or CRO.
• Strong understanding of the R&D continuum (CMC, preclinical, clinical) and applicable laws, guidelines, and agency expectations.
• Demonstrated expertise in at least one regulatory domain (e.g., CMC, lifecycle maintenance, labeling, MA transfers, publishing).
• 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, follow SOPs consistently, and exercise sound judgment on discrete tasks.
• Problem‑solving mindset with adaptability in fast‑changing environments; self‑motivated and collaborative.
• Applicable certifications/licenses as required by local regulations.
• Experience with EU (EMA) and/or US (FDA) submissions is a plus; biotech therapy area exposure welcomed.

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.