Open Position
Title: Senior Specialist/Manager Regulatory Operations
Location: Remote – or North Carolina
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
This role supports all aspect of TG Regulatory Affairs and Operations, including planning, preparing and delivering high-quality documents for regulatory submissions of investigational and marketed products worldwide. The position requires expertise on US, EU and ICH standards for regulatory submissions, attention to detail, and ability to confirm that submission documents meet Health Authority requirements. This role will report to the Associate Director, Regulatory and Development Strategy. We are looking for a highly motivated individual, who can be a team player and an independent thinker.
Key Responsibilities
––Managing multiple regulatory submissions for INDs and BLAs
––Developing submission content plans and submission timelines including SUSARs
––Leading and driving cross-functional teams focused on the execution of regulatory submission including anticipating regulatory obstacles, identifying emerging issues, and proactively developing solutions
––Identifying and elevating key areas of regulatory risk.
––Coordinating with cross functional teams to compile various submissions and work with vendors in a timely manner to meet regulatory timelines.
––Working closely with product safety and regulatory affairs team to learn the responsibilities of the various jobs within the department and across teams.
––Preparing and reviewing standard operating procedures.
––Representing Regulatory Operations in small project teams.
––Facilitating submission planning meetings to ensure clear communication of the project plan, action items, risks, and decisions to the team
––Reviewing dossiers to ensure submissions are of the highest quality and delivered on time
––Contributing to the development of regulatory submission plans and timelines, ensuring alignment with development milestones and strategic goals
––Performing other duties as assigned
Professional Experience/Qualifications
Thorough knowledge and understanding of Health Authority regulations, guidance documents and the drug development process
––Demonstrates an expert understanding of document preparation process and role of each contributing discipline
––Demonstrate ability to work cross-functionally to develop project plans, proactively identify risks, develop risk mitigation strategies, communicate project team decisions and project status
––Proficient with MS Office and Adobe Acrobat
––Ability to work independently and collaboratively in a fast-paced environment with internal and external team members
––Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
––Excellent planning, organization and time-management skills, including the ability to support and prioritize multiple projects
––Independent, able to multitask, self-motivated
––Methodical, organized, highly detail-oriented, works effectively under pressure
––Excellent written and verbal communication skills
Education
––BS degree in pharmaceutical sciences, biochemistry, biology, public health, or a similar field.
––Advanced degree (Masters or PharmD) preferable
––A minimum of 2 years industry experience in Regulatory Affairs or Project Management
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.