[Hiring] Senior Regulatory Affairs Specialist @Iovance Biotherapeutics

Role Description

Iovance seeks a highly motivated Senior Regulatory Affairs Specialist. The successful candidate has substantial experience planning and managing regulatory authority submissions. They will independently manage multiple clinical programs and contribute to the execution of major submissions and responses to regulatory authorities related to IND/NDA submissions and amendments.

• Support preparation of briefing packages for FDA meetings.
• Support the preparation and submission of routine regulatory documents such as Annual Reports/DSURs, Investigator Packages, and SUSARs.
• Represent Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives.
• Plan and manage submissions with attention to detail in written correspondence and regulatory files.
• Work with diverse internal and external stakeholders.

Qualifications

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred.
• Strong scientific or research background, with a focus in pharmacy, chemistry, or biology preferred (or relevant experience).
• Minimum 8 years’ experience in regulatory affairs or a related function in drug/biologic development.
• Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus.
• Understanding of US and international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
• Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
• High attention to detail and accuracy.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to work independently with minimal supervision or direction.
• Comfortable in a fast-paced small company environment with minimal direction.

Requirements

• Responsible for submission planning and oversight of IND related activities like Annual reports, Orphan drug reports, DSUR, and other CTA activities.
• Manage the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
• Prepare routine IND and CTA amendments, including Annual Reports/DSURs, Investigator Packages, and SUSARs.
• Independently manage Vendors/CROs for planning and tracking of source documents.
• Support the implementation of regulatory strategy for assigned projects and programs.
• Work with submission authors and reviewers to ensure high-quality documents are approved on-schedule.
• Maintain logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies.
• Prepare templates or shells for specific submissions based on company standards.
• Prepare and compile effective presentations for external and internal audiences as needed.
• Other duties as assigned.

Benefits

• Annual base salary: $140,000 — $160,000 USD.
• Equal-opportunity employer with a commitment to diversity and inclusion.

Work Environment

• This job operates in a professional or remote office environment.
• Requires operating standard office equipment and keyboards.