Associate Director – Regulatory Affairs

Iovance Biotherapeutics, Inc.

Leading one or more drug development programs and regulatory strategy at Iovance Biotherapeutics. Collaborating with global regulatory authorities for biologic products in oncology indications.

Posted 6/25/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $170,000 - $200,000 per yearWebsite

About the role

Key responsibilities & impact

Collaborates closely with functional leaders to create the optimal development path for Iovance product candidates.
Negotiates optimal development paths within cross-functional teams and with health authorities.
Executes clinical-regulatory development plans on-time and while managing all identified risks.
Plans, manages, and creates Clinical Trial Applications, Market Applications, and amendments.
Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
Leads cross-functional teams in developing strategic briefing packages and in preparing for health authority meetings or interactions.
Ensures that evolving global regulations, guidelines, and health authority expectations are incorporated into program decision making.
Works within the department and with other functional areas on process improvements.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Requirements

What you’ll need

BS degree in life sciences required.
Minimum 10 years’ experience in regulatory affairs with a Bachelor’s degree, 8 years with a Master’s degree, or 5+ years with a PhD.
Late‑stage experience in oncology drug development.
Experienced in creating and negotiating the clinical-regulatory aspects of oncology drug development programs with health authorities, including Ex-US.
Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents, e.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries.
Able to write clearly and concisely, within agreed timelines.
Able to simultaneously manage multiple projects and submissions, 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.
Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
Excellent interpersonal, verbal, and written communication skills.

Benefits

Comp & perks

Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
Iovance is committed to cultivating and offering a diverse and inclusive work environment.
Equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsclinical trial applicationsoncology drug developmentclinical-regulatory documentsbriefing booksinvestigator brochuresclinical study reportsclinical summariesproject managementrisk management

Soft Skills

attention to detailorganizational skillsplanning skillsinfluencenegotiationinterpersonal skillsverbal communicationwritten communicationcollaborationflexibility

Certifications

BS degree in life sciencesMaster's degreePhD