Manager, Regulatory Affairs

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

📋 Description

• Oversees the planning, compilation, quality control, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.

• Prepares routine amendments for IND and Clinical Trial Applications (CTAs).

• Collaborates with submission authors and reviewers to ensure comprehensive planning of source documents and that high-quality documents are approved in a timely manner.

• Represents the Regulatory Affairs department and offers regulatory expertise to cross-functional teams on designated projects and topics.

• Assists in the creation and management of Gantt charts (in partnership with Program Management) and trackers for submissions across multiple products.

• Maintains records of IND and CTA submissions, along with correspondence with the FDA or other regulatory bodies.

• Prepares templates or frameworks for specific submissions in accordance with company standards.

• Performs additional duties as assigned.

⛳️ Requirements

• A BA/BS degree in a relevant field is required.

• Minimum of 8 years of experience in regulatory affairs or a related role in drug/biologic development with a Bachelor's degree; 6+ years with a Master's degree; or 4+ years with a PhD.

• Experience managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format.

• Comprehensive understanding of international regulations and procedures in drug/biologics development, along with familiarity with ICH and regional regulatory requirements.

• Strong organizational and planning abilities; skilled in influencing and negotiating professionally at various levels within the project team and with external partners while maintaining positive working relationships.

• Proficient in Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.

• Meticulous attention to detail and accuracy.

• Exceptional interpersonal, verbal, and written communication skills.

• Comfortable working in a dynamic small company setting with minimal oversight and capable of adjusting workload based on changing priorities.

🏝️ Benefits

• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

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