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Manager, Regulatory Affairs CMC

2 weeks, 4 days ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Iovance Biotherapeutics

Iovance Biotherapeutics

Iovance Biotherapeutics is a biopharmaceutical company pioneering TIL therapy to treat cancer by utilizing the patient's immune system to target cancer cells.

Pharmaceuticals
251-1K
Founded 2007
View All Jobs 6

Description

  • Manage the planning, compilation, quality control, and submission of INDs, BLAs, and related amendments.
  • Prepare routine IND and CTA amendments.
  • Work with submission authors and reviewers to ensure source document planning is complete and documents are approved on schedule.
  • Represent Regulatory Affairs and provide regulatory expertise to cross-functional teams on assigned projects and topics.
  • Collaborate with Quality Assurance, clinical manufacturing, commercial manufacturing, and other stakeholders to maintain a robust change control program.
  • Develop CMC regulatory strategy for product changes across all stages of development.
  • Work within the CMC Regulatory Affairs team to build consensus on proposed changes.
  • Negotiate with internal stakeholders to ensure proposed changes and submission content align with ICH guidelines, country regulations, and industry standards.
  • Participate in risk mitigation by identifying risks and developing options and contingency plans.
  • Maintain submission trackers, Gantt charts, logs of IND and CTA submissions, and correspondence with FDA and other regulatory agencies.

Requirements

  • BA/BS degree in a related field.
  • At least 8 years of experience in regulatory affairs or a related function in drug or biologic development.
  • Experience managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format.
  • Broad understanding of international drug and biologics regulations and procedures, including familiarity with ICH and regional requirements.
  • Strong organizational and planning skills, with the ability to influence and negotiate professionally across project teams and external partners.
  • Advanced proficiency with Microsoft Office Suite (Word, PowerPoint, Excel) and Adobe Acrobat Pro.
  • High attention to detail and accuracy.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to work in a fast-paced small company environment with minimal direction and shifting priorities.
  • Advanced degree preferred, or equivalent relevant experience.

Benefits

  • Remote office work environment.
  • Annual base salary range of $140,000 to $160,000 USD.
  • Opportunity to work in a professional environment supporting a global leader in tumor infiltrating lymphocyte (TIL) therapy.
  • Equal-opportunity employer with a diverse and inclusive work environment.
  • Reasonable accommodations available upon request during the application and employment process.

Interested in this position?

Apply directly on the company website

Apply Now

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