Associate Director, Regulatory Affairs

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

📋 Description

• Oversee one or more drug development initiatives, focusing on global Ex-US regulatory strategies, submissions, and engagement with international regulatory bodies.

• Partner with functional leaders to establish optimal development pathways for product candidates.

• Facilitate negotiations regarding development strategies within cross-functional teams and with health authorities.

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

• Organize, oversee, and prepare Clinical Trial Applications, Market Applications, and their amendments.

• Ensure that submission documents and correspondence uphold high standards of content, organization, clarity, and accuracy.

• Lead cross-functional teams in crafting strategic briefing packages and preparing for meetings and interactions with health authorities.

• Integrate evolving global regulations, guidelines, and expectations from health authorities for biologics or Advanced Therapy Medicinal Products (ATMPs), including cell therapy products, into program decision-making.

• Collaborate within the department and with other functional areas to enhance processes.

• Uphold Iovance Biotherapeutics’ core values, policies, procedures, and ethical standards in business practices.

• Carry out miscellaneous tasks as assigned.

• Report directly to the Senior Director of Clinical Regulatory Affairs.

⛳️ Requirements

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

• At least 5 years of experience in regulatory affairs with an advanced degree, or 7 years with a BS degree.

• Experience in late-stage oncology drug development.

• Proven track record in developing and negotiating clinical-regulatory aspects of oncology drug development programs with health authorities outside the U.S.

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

• Ability to write in a clear and concise manner within established timelines.

• Proficient in managing multiple projects and submissions simultaneously, with the agility to adapt based on new data, program alterations, and external influences.

• Exceptional attention to detail and accuracy.

• Strong organizational and planning abilities.

• Capability to influence and negotiate professionally at various levels within cross-functional teams and with external partners.

• Outstanding interpersonal, verbal, and written communication skills.

• Must be able to maintain a stationary position, whether standing or sitting, for extended periods.

• Must be capable of moving about within an office setting and exerting up to 10 pounds of force occasionally or a negligible amount frequently or constantly.

• Requires visual acuity for preparing and analyzing data and figures, viewing a computer screen, and extensive reading.

• Involves repetitive motion of the wrist, hands, and/or fingers.

• Must be able to communicate effectively with others to exchange information.

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.

• Ability to manage work-related stress, multiple priorities, and meet deadlines.

• Competent in operating standard office equipment and keyboards.

🏝️ Benefits

• Reasonable accommodations may be provided upon request.

• A diverse and inclusive work environment.

• Commitment to equal-opportunity employment.

• Assistance or accommodation to apply is available upon request.