Associate Director – Regulatory Affairs

Iovance Biotherapeutics, Inc.

. Lead one or more drug development programs, focusing on US and global (Ex-US) regulatory strategy, regulatory submissions, and interactions with global regulatory authorities .

Posted 9/30/2026full-timeRemote • United StatesSenior💰 $185,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for drug development, particularly in oncology, with a strong focus on creating and negotiating clinical-regulatory documents and submissions. Proven ability to lead cross-functional teams and manage multiple projects while adhering to high standards of accuracy and detail.

Highest-signal resume keywords

Regulatory Affairs ExperienceOncology Drug DevelopmentClinical Trial ApplicationsHigh-Quality Document PreparationCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsClinical-Regulatory Development PlansClinical Study ReportsInvestigator BrochuresProtocolsClinical SummariesNegotiation SkillsProject ManagementAttention to DetailAnalytical Skills

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsProblem-Solving SkillsStress Management

Certifications & Qualifications

BS Degree in Life SciencesDoctorate Degree (MD, PhD, PharmD) or Equivalent

Industry Keywords

BiologicsATMPsHealth Authority InteractionsGlobal Regulatory StrategyClinical Trial ManagementMarket ApplicationsOncologyDrug Development Programs

About the role

Key responsibilities & impact

Lead one or more drug development programs, focusing on US and global (Ex-US) regulatory strategy, regulatory submissions, and interactions with global regulatory authorities
Collaborate with functional leaders to create and negotiate optimal development paths for Iovance product candidates
Execute clinical-regulatory development plans on time while managing identified risks
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments
Ensure submission documents and correspondence meet high standards for content, organization, clarity, and accuracy
Lead cross-functional teams in developing strategic briefing packages and preparing for health authority meetings and interactions
Incorporate evolving global regulations, guidelines, and health authority expectations for biologics and ATMPs, including cell therapy products, into program decisions
Work within the department and with other functional areas on process improvements
Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
Perform miscellaneous duties as assigned

Requirements

What you’ll need

BS degree in life sciences required
Minimum 5 years of experience in regulatory affairs with a doctorate degree (ie, MD, PhD, PharmD, or equivalent), 8 years with Master’s Degree, or 10 years with a Bachelor’s degree
Late-stage experience in oncology drug development
Experience creating and negotiating clinical-regulatory aspects of oncology drug development programs with health authorities, including Ex-US
Ability to write, edit, and/or collaborate on high-quality clinical-regulatory documents, including briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries
Ability to write clearly and concisely within agreed timelines
Ability to manage multiple projects and submissions simultaneously, with flexibility to pivot based on new data, program changes, and/or external influences
High attention to detail and accuracy
High organizational and planning skills
Ability to influence and negotiate professionally within cross-functional teams and with external partners
Excellent interpersonal, verbal, and written communication skills
Must be able to remain standing or sitting for prolonged periods
Must be able to move about inside an office and exert up to 10 pounds of force occasionally or negligible force frequently or constantly
Visual acuity for preparing and analyzing data and figures, viewing computer screens, and extensive reading
Ability to perform repetitive wrist, hand, and finger motions
Ability to communicate with others to exchange information
Clear and conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, stress management, prioritization, and deadline management