Open Position
Title: Associate Director/Director – US Regulatory Advertising and Promotion
Location: Remote (preference for East Coast time zone)
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 an experienced and strategic Director, US Regulatory Advertising and Promotion to lead and manage regulatory strategies for advertising, promotion, and labeling activities of our products in the U.S. This individual will report to the General Counsel and be responsible for ensuring that all promotional materials and activities comply with applicable U.S. regulations, including FDA guidelines and other regulatory requirements. The ideal candidate will have a deep understanding of the regulatory landscape, a proven track record of working with cross-functional teams, and the ability to communicate regulatory risks and strategies to company leadership.
Key Responsibilities
––Regulatory Strategy & Oversight: Lead the regulatory review as a member of the MLR review team of advertising and promotional materials for compliance with FDA, FTC, and other applicable U.S. regulations, guidelines, and internal company standards and policies. Actively contribute to the development and implementation of promotional review process.
––Cross-Functional Collaboration: Work closely with marketing, legal, medical affairs, and commercial teams to ensure that all activities are aligned with regulatory requirements. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk
––Regulatory Submissions: Oversee the preparation and submission of regulatory documents related to promotional materials, including Form FDA 2253 submissions, and ensure timely approval from the FDA. Serve as primary point of contact with FDA, regarding promotional materials, establishing strong and positive working relationships with OPDP reviewers
––Risk Management: Identify potential regulatory risks in promotional materials and provide guidance to mitigate any issues that may arise. Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics.
––Training & Education: Provide regulatory training and guidance to internal stakeholders to ensure a consistent understanding of regulatory advertising and promotion requirements.
––Regulatory Intelligence: Stay current with evolving regulatory guidelines, industry trends, and FDA policies related to advertising and promotion, and incorporate this knowledge into internal practices and strategies.
Travel 10-15% to TG’s offices to attend meetings, etc., as required.
Professional Experience/Qualifications
––5+ years of experience in regulatory affairs or related roles, with at least 3-5 years focused on regulatory advertising and promotion.
––Strong understanding of FDA regulations, particularly with respect to the advertising and promotion of prescription drugs, biologics, or medical devices in the U.S.
––Experience with the FDA’s promotional review process, including Form FDA 2253 submissions and labeling guidance.
––Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch.
––Strong analytical and problem-solving skills.
––Excellent verbal and written communication skills, with the ability to communicate complex regulatory issues clearly to non-regulatory stakeholders.
––Proven ability to lead cross-functional teams and manage multiple projects simultaneously.
––Detail-oriented with a focus on compliance and risk management.
––Experience in both the pharmaceutical/biopharmaceutical and medical device sectors is a plus.
––Knowledge of global promotional regulations and practices.
––Familiarity with digital and social media regulatory considerations for promotion is a plus.
Experience working in a small biotech setting preferred.
Education
––Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field; advanced degree (e.g., M.S., Ph.D., or JD) 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.