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.
––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
––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