Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.
Manager, Regulatory Affairs, CMC
Location
United States
Posted
17 days ago
Salary
$140K - $160K / year
Seniority
Lead
Job Description
Manager, Regulatory Affairs, CMC
Iovance Biotherapeutics, Inc.
• Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments. • Prepares routine IND and CTA amendments. • Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule. • Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics. • Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program. • Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development. • Work within the CMC Regulatory Affairs team to gain consensus on proposed changes. • Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards. • Participate in risk mitigation by proactively identifying risk, developing options and contingency plans. • Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers for submissions across the multiple products. • Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.
Job Requirements
- BA/BS degree in related field required.
- At least 8 years’ experience in regulatory affairs or a related function in drug/biologic development.
- Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format.
- Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
- Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
- Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
- High attention to detail and accuracy.
- Excellent interpersonal, verbal and written communication skills.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Benefits
- Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
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