Director, Regulatory Affairs - Advertising & Promotion

ITF Therapeutics•Concord, MA

4h•$215,000 - $240,000

About The Position

The Director, Regulatory Affairs, Advertising & Promotion will be a key commercial regulatory contributor responsible for providing strategic and operational support across promotion and non-promotional communications. This role provides guidance and review of material on the Medical, Legal, Regulatory (MLR) team and ensures all materials are accurate, balanced, and aligned with regulatory requirements. As a critical partner across the organization, this leader helps advance ITF’s mission to deliver innovative and lifechanging therapies with urgency, ambition, and compassion for the rare disease communities we serve.

Requirements

Has excellent communication, influence, and cross-functional alignment and collaboration skills
Ability to distill complexity into understandable and actionable language
Strong attention to detail, organizational skills, and ability to manage multiple priorities
Have strong regulatory judgement, a practical approach to risk, and the ability to work closely with internal stakeholders in a fast-paced environment
Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred
8-10+ years of progressive Regulatory Affairs experience within biotech and/or pharmaceuticals
5+ years of direct experience in prescription drug advertising and promotion review
Experience interfacing with OPDP, including advisory comments and FDA Form 2253 submissions
Experience reviewing a wide range of promotional materials across digital and traditional channels
Ability to interpret clinical data and apply it appropriately in promotional contexts
Knowledge of clinical study design and statistical analyses in the assessment of promotional claims
Demonstrated experience developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders
Willingness to travel to various meetings or sites, including overnight trips

Responsibilities

Review, approve and provide regulatory guidance on content of materials created for product promotion, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices
Represent the commercial regulatory perspective at the promotional review committee (MLR) which includes cross functional partners from Marketing, Medical Affairs, and Legal/Compliance
Lead discussions in review committees, collaborating with stakeholders from Legal, Medical, and commercial teams to reach consensus on promotional materials.
Serve as internal lead on FDA regulations, guidance and enforcement trends governing the promotion of our products
Assume a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities
Manage interaction with the Office of Prescription Drug Promotion OPDP including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission of promotional materials under cover of FDA Form 2253
Ensure stakeholder awareness on planned and approved label updates and how they impact Promotional and Medical materials. Provide key stakeholders with guidance on implementation of ISI, and labels in a timely manner.
Align and maintain effective and collaborative communication channels with Medical, Marketing, Regulatory, Legal, and corporate counterparts
Provide training on FDA regulations for advertising and promotion to employees and agents of our company
Assist on the development strategies of US labeling to ensure support for anticipated promotional messages and claims.
Monitor and interpret enforcement trends, evolving regulations, and industry best practices.
Optimize PRC processes, documentation, workflows, and review systems.