Open Position
Title: Manager/Senior Manager – Regulatory Submissions
Location: Raleigh, NC or Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
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 U.S. Food and Drug Administration (FDA) approval 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, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
We are seeking a motivated and detail-oriented Regulatory Operations professional to join our Regulatory Affairs team and report to the Associate Director, Global Regulatory Affairs. The successful candidate will play a key role in planning, preparing, and submitting global regulatory applications, including Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs) and combination product submissions (drug-device).
This role will collaborate closely with cross-functional teams, including Regulatory Affairs, CMC, and Clinical, to ensure timely, accurate, and compliant submissions that support the company’s product development and commercialization goals.
Key Responsibilities
––Plan, compile, and publish regulatory submissions (e.g., INDs, CTIS, BLAs, MAAs, amendments, supplements, briefing packages) in eCTD format in accordance with global health authority requirements
––Serve as submission lead for major applications, managing timelines and coordinating with internal contributors and external vendors
––Support lifecycle management of existing submissions, ensuring accuracy, compliance, and version control across all modules
––Collaborate with development leaders to establish and track submission strategies and timelines
––Maintain submission tracking systems and ensure completeness and consistency across documents and metadata
––Coordinate third-party interactions with health authority portals (e.g., FDA ESG, EMA, MHRA) and troubleshoot submission issues as needed
––Ensure compliance with current regulatory standards, including ICH, FDA, and EMA eCTD specifications
––Participate in the development and maintenance of Regulatory Operations SOPs and templates
Preferred qualifications:
––Experience with Marketing Authorization Applications (MAAs) and Clinical Trial Applications (CTR) in the EU or UK.
––Familiarity with combination product submissions (drug-device), including applicable regional requirements
––Knowledge of global submission pathways and regional differences in electronic requirements
––Experience with FDA and/or EMA regulatory interactions (Type B, Scientific Advice, etc.)
Professional Experience/Qualifications
––3+ years of hands-on experience in Regulatory Operations within the biotech or pharmaceutical industry.
––Proven experience leading or supporting Biologics License Applications (BLAs) from planning through submission and approval
––Strong working knowledge of eCTD publishing tools and regulatory requirements (FDA, EMA, ICH)
––Proficiency in document formatting and lifecycle management systems (e.g., Veeva Vault RIM)
––Strong attention to detail, organization, and communication skills
Education
––Bachelor’s degree in life sciences or related field (advanced degree a plus)
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.