Director, Regulatory Affairs Advertising Promotion Operations
Green Line Talent Group
·Today
- Workplace
- Remote
- Type
- Full-time
- Department
- Marketing
- Seniority
- Director
- Experience
- 10+ years
- Education
- Bachelor
- Closing date
- Today
- Source
- CareersPage
Description
Location: Remote
Reports to: VP of Regulatory Affairs, Advertising, Promotion, Labeling
About Veradermics
Founded in 2019, Veradermics, Incorporated (NYSE: MANE) is a well-funded, publicly listed company that offers the opportunity to work in a performance-driven, highly dynamic environment. At Veradermics, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Veradermics is a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions.
Veradermics lead product candidate, VDPHL01, is as an oral, non-hormonal treatment for men and women with pattern hair loss (PHL). We are currently conducting three Phase 3 clinical trials as we work to deliver potentially transformative solutions and aspire to redefine the standard of care in dermatology. Learn more here.
At Veradermics, we combine scientific rigor with a vision for impactful innovation to make a lasting difference in the lives of patients.
Why Work at Veradermics
- You Can Be Part of a Meaningful Mission: Veradermics aims to become a leader in medical dermatology by bringing pharmaceutical innovation to the treatment of common skin conditions to improve the lives of patients.
- Veradermics is Growing: Veradermics is a dynamic and growing company; we are advancing our VDPHL01 Phase 3 clinical trials and preparing for commercialization. PHL affects approximately 80 million people in the U.S. alone.
- The Veradermics Culture: We are an innovative, collaborative, hard-working and performance-driven company that values the contributions of our employees and keeps our focus on patients
- We have been featured in Forbes, Allure, Marie Claire, Bazaar, Dermatology Times, the Slate, The New York Post, The Hartford Courant, The Kansas City Star, and other multi-media platforms.
Position Overview
The Director, Regulatory Affairs Advertising Promotion Operations is responsible for leading the operational execution and governance of the company's Medical, Legal, and Regulatory (MLR) review process, promotional review governance, and FDA Form 2253 submission activities. Reporting to the Vice President, Regulatory Affairs Advertising Promotion & Labeling, this role will oversee promotional review systems, processes, and cross-functional workflows to ensure regulatory compliance, operational efficiency, launch readiness, and scalable support for commercial growth.
The Director will partner closely with Regulatory Affairs, Commercial, Medical Affairs, Legal, and Compliance stakeholders to drive review committee effectiveness, promotional material submission compliance, and continuous process improvement.
Key Responsibilities
- Serve as the system owner for the enterprise-wide software system of review through strategic collaboration with commercial, med affairs, and legal stakeholders to support company objectives, launch readiness, and organizational scalability.
- Build and optimize operational the MLR infrastructure, governance frameworks, and business processes across the review committee.
- Assist in the development, training, and maintenance of review committee SOPs, submission standards, and governance documentation.
- Maintain operations technologies and platforms for system of review, 2253 archival and organizational platforms
- Collaborate with medical affairs, commercial, and other stakeholders on project plans and timelines, ensuring operational preparedness for the launch of VDPHL01.
- Develop efficient and cost-effective 2253 process including strategic review of external and internal systems options for submission of materials through the eCTD gateway.
- Serve as the day-to-day lead for Ad Promo operations including coordination for all material submissions, planning and calendaring
- Facilitate all review committee meetings, office hours, prioritization, and launch planning meetings
- Drive continuous process improvement initiatives through KPI development, analytics, reporting dashboards, and operational metrics.
- Other regulatory operations tasks, to be identified.
Candidate Profile | Who You Are
- Bachelor's degree or minimum of 10+ years of experience within biotech, pharmaceutical, or regulated healthcare industries.
- Demonstrated experience standing up enterprise-wide PRC processes, systems, governance, and operational frameworks to support scalable review and launch readiness.
- Experience in preparing and submitting promotional materials to the FDA on form 2253 through eCTD
- Demonstrated leadership of review committee processes and promotional compliance.
- Experience with Veeva Vault, Smartsheet, and other project management platforms.
Company Culture
Veradermics is a small, tight-knit, high-performing team that works with urgency, positivity, and a deep sense of ownership. We set an exceptionally high bar for ourselves and seek someone who is energized by playing an integral role in a fast-moving organization at a pivotal moment in our trajectory- bringing curiosity, clarity, and a drive to get things done at the highest level.
We value strong organization, thoughtful collaboration, and genuine investment in team success. Honest, direct communication is central to how we work and grow together. Accomplishing our collective goals will be fun but also complex.
Location and Travel
- Location: Remote
- Travel: ~10%
Salary and Benefits
Veradermics provides a comprehensive compensation package that includes a base salary, annual performance bonus eligibility, and access to the employee stock option plan.
Robust benefits package, including health coverage, retirement benefit matching, dependent care FSA, and unlimited paid time off.
Equal Opportunity Employer
Veradermics is an equal opportunity employer. All employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, or age.