Associate Director – Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborates closely with functional leaders to establish the ideal development pathway for Iovance product candidates.

• Negotiates the best development pathways within cross-functional teams and with health authorities.

• Implements clinical-regulatory development plans punctually while managing all identified risks.

• Plans, oversees, and prepares Clinical Trial Applications, Market Applications, and amendments.

• Ensures submission documents and correspondence maintain the highest quality regarding content, organization, clarity of writing, and accuracy.

• Guides cross-functional teams in formulating strategic briefing packages and preparing for interactions or meetings with health authorities.

• Ensures that evolving global regulations, guidelines, and health authority expectations are integrated into program decision-making.

• Collaborates with department and other functional areas to enhance processes.

• Must comply with Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

⛳️ Requirements

• A Bachelor’s degree in life sciences is required.

• A minimum of 10 years’ experience in regulatory affairs with a Bachelor’s degree, 8 years with a Master’s degree, or over 5 years with a PhD.

• Experience in late-stage oncology drug development.

• Proficient in creating and negotiating the clinical-regulatory aspects of oncology drug development programs with health authorities, including those outside the U.S.

• Capable of writing, editing, and/or collaborating on the development of high-quality clinical-regulatory documents, such as briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries.

• Able to write clearly and succinctly, adhering to agreed timelines.

• Capable of managing multiple projects and submissions simultaneously, with the flexibility to adapt based on new data, program changes, and/or external factors.

• Strong attention to detail and accuracy.

• Excellent organizational and planning abilities.

• Skilled in influencing and negotiating professionally at various levels within cross-functional teams and with external partners while fostering positive working relationships.

• Outstanding interpersonal, verbal, and written communication skills.

🏝️ Benefits

• Reasonable accommodations may be provided upon request to enable individuals to perform essential functions.

• Iovance is dedicated to fostering and providing a diverse and inclusive work environment.

• As an equal-opportunity employer, our employees and applicants are 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, or any other characteristic protected by applicable law.