Open Position

Title: Director, Global Regulatory Affairs

Location: Remote or North Carolina or NY/NJ Region

If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.


The Director, Global Regulatory Affairs is responsible for the planning, management, support and execution of global regulatory activities related to TG Therapeutics’ multiple sclerosis, autoimmune, and oncology portfolios. The Director leads planning and implementation of global regulatory submissions in collaboration with cross-functional team members and senior management as well as TG Therapeutics’ point of contact for interactions with global regulatory agencies. The Director reports to the Chief Development Officer of TG Therapeutics.

Key Responsibilities

Contribute to the development and implementation of preclinical and clinical strategies for projects in all stages of development (preclinical through marketing application)

Work cross-functionally with representatives from Clinical, Pharmacovigilance, CMC, Commercial, and other TG Therapeutics functions on matters related to regulatory affairs

Interact with the US FDA, EMA, other global health authorities, and contract research organizations on matters related to regulatory affairs

Work cross-functionally to develop the strategies, execution plans and documentation of regulatory submissions, including clinical trial applications, Investigational New Drug (IND) applications, Biologics Licensing Applications (BLA), New Drug Applications (NDA), and Marketing Authorization Approvals (MAAs).

Prepare regulatory agency responses and other documents intended for submission to global health authorities, including information requests, meeting requests, and briefing documents

Manage the cross-functional development of documents and other assigned tasks within established timelines and with high quality

Maintain awareness of global health authority views and guidance on topics related to drug development and integrate learnings into the broader TG Therapeutics organization

Professional Experience/Qualifications

Operational knowledge of FDA regulatory requirements for the development and registration of drug products

Leading cross-functional teams to develop regulatory submission documents

Interacting with FDA representatives and organizing FDA meetings

Experience launching new products, working with FDA advisory committee meetings, or labeling negotiations is a plus

Managing complex projects

Working in a collaborative environment with challenging timelines


10+ years of regulatory experience in the biotech/pharmaceutical industry

Advanced degree (PhD, PharmD, MS) 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.