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Director of Regulatory Affairs

Regulatory | New York, NY | Full Time

Job Description

About Us:

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202 (umbralisib), an orally available PI3K delta inhibitor for various hematologic malignancies. 

Responsibilities:

  • Responsible for the coordination, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, BLAs, DMFs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submissions and marketing applications to the FDA, and if required international regulatory authorities), and ensure appropriate follow-up correspondence.
  • Leads the hands-on preparation and coordination in preparation and authorship of regulatory documents in clinical programs, CMC, quality, process improvement and laboratory control.
  • Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities.
  • Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
  • Along with the CMO, serves as interface with reviewers from FDA and other health authorities.
  • Provide regulatory CMC expertise during due diligence and in support of new projects.
  • Coordinates activities for meetings with FDA and other regulatory authorities, and leads negotiations and interactions with regulatory authorities.
  • Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) to execute program objectives in compliance with applicable regulations.
  • Coordinates with cross functional teams to define contributions to submissions.
  • Maintains current knowledge of regulations and guidelines (FDA, ICH and other as required). 
  • Ensures compliance with health authority regulations.
  • Define global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.
  • Reviews clinical study protocols, clinical study reports, investigator brochures and CMC reports.
  • Interprets pre-clinical and clinical results and develop those into sound regulatory positions and strategy.
  • Develops and maintains cooperative relationships with external vendors and regulatory health authorities.
  • Communicate CMC regulatory strategy, key issues and remediation activities needed throughout project/product life cycle to project team and appropriate management levels within and outside of Regulatory CMC.

Professional Experience and Qualification: 

  • A minimum of 10 years of Regulatory CMC experience as well as additional experience in the biopharmaceutical industry; the regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as US, EU, Japan and Canada).
  • Knowledge/experience of regulations, guidelines for NCEs and product life cycle
  • Knowledge of Drug Substance and Drug Product development and manufacturing processes
  • In addition to above: Record of achievement of regulatory approvals and demonstrated success in working with regulatory authorities and/or toll manufacturers.
  • In depth knowledge of U.S. and European Regulatory and pharmaceutical issues
  • Exceptional analytical and problem-solving skills; extensive medical, scientific and/or technical knowledge pertaining to pharmaceutical development or operations good judgment; exceptional interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting; effective communication skills; flexibility; self-confidence, achievement-oriented with appropriate concern for quality are highly desirable qualifications.
  • Exceptional written and verbal communication skills including ability to persuasively communicate
  • Effective interpersonal skills with the ability to work in a team-based setting
  • Extensive customer interactions with R&D functions, QA, Manufacturing and other teams within Regulatory Affairs

Education:

  • BS, BSc, MS, MSc, PhD, PharmD in science or healthcare preferred or equivalent relevant experience.

Travel:

  • 10% to 30% domestic/international