TG Therapeutics, Inc. · 2 days ago

Associate Director/Director, US Regulatory Advertising and Promotion

United States

Full-time

Remote

Director/Executive

5+ years exp

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Hiring Manager

Rachel Berger-Rosas

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Responsibilities

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.

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

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

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.

Provide regulatory training and guidance to internal stakeholders to ensure a consistent understanding of regulatory advertising and promotion requirements.

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.

Qualification

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Regulatory AffairsFDA RegulationsPromotional Review ProcessForm FDA 2253Compliance FocusPharmaceutical ExperienceDigital Media Regulations

Required

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.

Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.