---
title: 'Director, Regulatory Affairs (Advertising and Promotions) at Definium Therapeutics'
canonical: 'https://feeny.ai/job/director-regulatory-affairs-advertising-and-promotions-definium-therapeutics-yttv1kff5hzj'
type: 'job'
last_seen: '2026-10-13'
---

# Director, Regulatory Affairs (Advertising and Promotions) at Definium Therapeutics

- **Company:** Definium Therapeutics
- **Location:** Remote
- **Compensation:** $215k–$255k
- **Work type:** remote
- **Posted:** 2026-09-30
- **Last confirmed live:** 2026-10-13
- **Apply:** https://job-boards.greenhouse.io/definiumtherapeutics/jobs/6209694004

## Job description

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.

Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.

Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!

Definium seeks an experienced promotional reviewer to join our Regulatory Affairs team.   The Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications, and social media postings for assigned brand(s). This colleague will provide regulatory guidance related to promotional and advertising campaigns for marketed products and development programs. This role will also provide input into labeling strategies for marketed products and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s). The individual will be responsible for the review of all submission types made to OPDP/APLB (FDA). The incumbent’s responsibilities include providing review of promotional and medical materials and functioning as a leader during the Medical, Legal, Regulatory (MLR) review process, providing clear guidance to ensure compliance with regulatory standards. This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, and Legal functions for the purpose of providing regulatory advice and guidance during promotional plan development from concept to field implementation, assuring conformity with FDA requirements, PhRMA DTC Guidelines, and Definium policies.

Responsibilities:

- Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations
- Review and approval of promotional and medical materials in Definium’s PromoMats system
- Represent the regulatory perspective in live MLR meetings and concept reviews
- Review and approval of social media posts
- Liaise with OPDP/APLB (FDA) as needed for assigned product(s) serving as our company's single point of contact with FDA on matters related to advertising and promotional materials
- Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff
- Ensure timely and accurate FDA 2253 submissions of US promotional materials
- Ensure that changes and updates in prescribing information are reflected in current promotional and advertising materials
- Aid in the development of processes and standards for promotional materials and related activities to facilitate streamlined workflows and encourage an efficient review process
- Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy with respect to best practices in compliance with company policies and guidelines for PRC processes

Qualifications:

- Minimum BS in scientific discipline, advanced degree in science preferred
- Minimum 10 years’ experience in the pharmaceutical industry with at least 5 years as a regulatory advertising and promotional reviewer
- Experience in CNS is a plus
- Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
- Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotional matters
- Experience in Veeva PromoMats a strong plus

Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!

The starting base pay range for this position: $215,000—$255,000 USD

## About Definium Therapeutics

## Company Overview
- **One-liner**: Definium Therapeutics is a clinical-stage biopharmaceutical company applying scientific rigor to psychedelic medicine to develop accessible treatments for psychiatric disorders.
- **Entity Type**: Public (NASDAQ: DFTX)
- **Headquarters**: Not specified in available sources; the company operates as a remote-first organization.
- **Founded**: 2019 (originally as MindMed)
- **Founders**: Not publicly available in provided sources.

## Core Business
- **Primary Industry**: Biotechnology / Psychiatric drug development (psychedelic medicine)
- **Target Customers**: Patients with major depressive disorder (MDD), generalized anxiety disorder (GAD), posttraumatic stress disorder (PTSD), and autism spectrum disorder (ASD); also healthcare providers and payers.
- **Mission/Purpose**: “Unlock healing at scale” by harnessing the full therapeutic potential of psychedelic medicine through precise, evidence-based science.

## Products & Services
- **DT120 ODT (Lysergide/LSD D-Tartrate Oral Disintegrating Tablet)**: Investigational drug for GAD, MDD, and PTSD. Currently in four Phase 3 trials (Voyage, Panorama, Emerge, Ascend) and a fifth planned for PTSD. FDA Breakthrough Therapy Designation for GAD. No adjunctive psychotherapy required.
- **DT402 (R(-)-MDMA)**: R-enantiomer of MDMA selected for serotonergic properties with a potentially superior tolerability profile. In Phase 2a study for social communication challenges in autism spectrum disorder.

## Market Standing
- **Valuation/Market Cap**: Not publicly available (publicly listed on NASDAQ as DFTX as of 2026, but recent market cap not provided in search results).
- **Key Metric**: Pre-revenue clinical-stage company; total funding history not disclosed in available sources.
- **Notable Investors/Partners**: Not disclosed in provided sources.
- **Growth Signals**:
  - Five Phase 3 trials ongoing or planned for DT120 ODT.
  - FDA Breakthrough Therapy Designation for DT120 in GAD.
  - Phase 2a trial initiated for DT402 in ASD.
  - Full results from Phase 2b GAD trial published in JAMA (2025).
  - Strong intellectual property with issued patents covering formulation, manufacturing, and treatment.

## Competitive Advantages
- **Proprietary Formulations**: Pharmaceutically optimized ODT for LSD (DT120) and novel R-enantiomer of MDMA (DT402) with potential improved tolerability.
- **Scientific Rigor**: Standalone drug studies without psychotherapy, enabling clearer efficacy and safety data.
- **Regulatory Momentum**: FDA Breakthrough Therapy Designation and multiple IND clearances.
- **Experienced Management Team**: Proven track record in developing and commercializing CNS therapies.
- **Comprehensive IP Strategy**: Patents covering drug formulations, methods of manufacture, and treatment use.

## Strategic Focus
- **Late-Stage Pipeline Advancement**: Completing Phase 3 trials for GAD and MDD, initiating PTSD trial.
- **Pipeline Expansion**: Advancing DT402 for ASD and exploring additional neuropsychiatric indications.
- **Commercial Readiness**: Building infrastructure (hiring VP of Sales, Senior Director of Field VEOR, etc.) to support potential future launch.
- **Data Generation**: Generating high-quality evidence to support regulatory submissions and differentiation.

## Why Work Here
- **Remote-First Culture**: “You can live anywhere in the country you’re employed in” (remote-first workforce).
- **Comprehensive Benefits**: 100% paid medical, dental, vision for employees and dependents; FSA/HSA; life and disability insurance.
- **Wellness & Time Off**: Annual wellness allowance, flexible PTO, company-wide shutdowns for rest.
- **Family Support**: Paid parental leave for birthing and non-birthing parents, 2-week return-to-work transition.
- **Financial Wellness**: Competitive compensation, 401(k) with employer match, employee equity (new hire grants and refreshes), Employee Stock Purchase Plan (ESPP) with discount.
- **Mission-Driven Work**: Opportunity to contribute to groundbreaking treatments in psychedelic psychiatry with a science-driven, collaborative team.

## Sources
1. [definiumtx.com](https://definiumtx.com/) – Company overview and pipeline details
2. [definiumtx.com](https://definiumtx.com/story/) – Company history, leadership, and strategic milestones
3. [definiumtx.com](https://definiumtx.com/careers/) – Careers page with benefits and remote-first policy
4. [definiumtx.com](https://definiumtx.com/research-development/) – Research and development pipeline details
5. [linkedin.com](https://www.linkedin.com/company/definiumtherapeutics) – LinkedIn company page

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