Novis TherapeuticsVerified Company

Regulatory Affairs Director (Oncology Biologics)

Posted by: Senior Director of Regulatory Affairs & Quality

Full-TimeHybrid - Cambridge MA, remoteExecutive (10+ yrs)$220,000 - $265,000 / yrPosted Sep 25, 2026

About The Job

Serve as the primary liaison with the FDA Center for Drug Evaluation and Research (CDER) for breakthrough monoclonal antibody therapeutics, providing strategic regulatory & compliance consulting.

Key Responsibilities

  • Lead regulatory strategy
  • Draft briefing documents for advisory committee hearings
  • Manage team of senior regulatory associates

Required Qualifications

  • PharmD, PhD, or Master’s in Life Sciences
  • 10+ years pharmaceutical regulatory affairs
  • Proven track record of BLA/NDA filings

Required Skills & Competencies

Regulatory & Compliance ConsultingFDA CDERBLA SubmissionsOncology TrialsLabeling Negotiations
Direct & Private Company SubmissionYour submitted CV, portfolio, and contact credentials will be sent directly to the hiring team at Novis Therapeutics. Healixity guarantees that your candidate profile is never shared publicly or resold.

Job Overview & Specifications

Job PositionRegulatory Affairs Director (Oncology Biologics)
Hiring LeadSenior Director of Regulatory Affairs & Quality
CategoryRegulatory Compliance
Healthcare FieldBiopharma & Oncology
WorkplaceHybrid
City, StateCambridge, MA
Zip Code02142
Employment TypeFull-Time
Experience LevelExecutive (10+ yrs)
Compensation$220,000 - $265,000 / yr

Novis Therapeutics

Verified Healthcare Organization

Active clinical healthcare partner recruiting top certified clinical and informatics specialists across North America.

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