Manager, Regulatory Affairs CMC

Benefits

Parental leave

Not verified

Non-birth-parent leave

Not verified

Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

Not verified

Relocation assistance

Not verified

Childcare support

Not verified

Learning budget

Not verified

Verification

Not verified checked Jun 13, 2026

Salary

$140K-$160K From the posting source checked Jun 20, 2026

401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

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Market context

U.S. role benchmark (BLS OEWS)

$61,842 U.S. median for this role

Projected growth (BLS Employment Projections)

+1.9% - Slower

U.S. benchmark only; posted salary is not compared across countries or currencies.

Matched to SOC 11-1021 - Operations aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Role

Role function

Operations From the posting source checked Jun 20, 2026

Seniority

Mid From the posting source checked Jun 20, 2026

Work mode

Remote From the posting source checked Jun 20, 2026

In-office days

0 days From the posting source checked Jun 20, 2026

Schedule

Shift type

Not verified

Weekend work

Not verified

Company

Company stage

Public-company From the posting source checked Jun 20, 2026

Equity

Offered Verified - SEC 10-K source checked Jun 20, 2026

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Manager, Regulatory Affairs CMC Remote Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Manager, Regulatory Affairs CMC, represents Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role. Essential Functions and Responsibilities - 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.

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