Director of Regulatory Affairs
Regulatory | New York, NY | Full Time
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.
- 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
- BS, BSc, MS, MSc, PhD, PharmD in science or healthcare preferred or equivalent relevant experience.
- 10% to 30% domestic/international