Manager/Sr. Manager, Regulatory CMC

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Open Position

Title: Manager/Senior Manager, Regulatory CMC

Location: Remote: New York or New Jersey

If you are interested in the below position, please send your resume to 

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Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in Morrisville, NC, New York City, and Edison, New Jersey. For more information, visit www.tgtherapeutics.com .

Role

The Manager/Sr Manager Regulatory CMC reports to the Vice President of Regulatory CMC. He/ she is responsible for managing the Company’s Regulatory CMC function to enable clinical development, marketing authorization, manufacture and distribution of clinical supplies and commercial products. He/ she supports the strategic and operational leadership required to ensure Regulatory CMC compliance with global (both US and ex-US) regulations and submission requirement for clinical studies and commercial supply.

The Manager/Sr Manager of Regulatory CMC is responsible for executing the strategy set by the Vice President of Regulatory CMC for clinical, post-marketing, new market registrations, regulatory commitments. He/ she ensures effective collaborations and partnership with Quality and technical functions within the Company, as well as external partners and suppliers. He/ she also supports the growth of the organization as development assets advance through the clinical research process and are commercialized for distribution.

Key Responsibilities

– Supports the coordination, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, 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 coordination, preparation, and authorship of regulatory documents in clinical programs, CMC, quality, process improvement and laboratory control.

– Coordinates and supports 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.

– Coordinates activities for meetings with FDA and other 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.

– Executes global CMC regulatory submissions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.

– Supports 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/Qualifications

3-5 years experience in regulatory CMC

Education

– – BS in a scientific field, advanced degree preferred

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.

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