Director, Regulatory Affairs Advertising & Promotion, US
The salary range for this position is between $205k and $240k.
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience. The company also currently offers a Long-Term Incentive Plan (cash plan) of 25% base salary, annual performance bonus target of 25% base salary (subject to meeting plan requirements) and comprehensive health benefits (employer funded), unlimited vacation time and 401k plan (subject to change or modification from time to time).
POSITION SUMMARY
The Director, Regulatory Affairs
Advertising & Promotion, US is responsible for developing and executing regulatory strategies for all advertising and promotional activities in the United States. This role serves as the primary expert on FDA requirements for the review of promotional, disease-state, and scientific exchange materials, ensuring all communications comply with applicable regulations. The position provides strategic regulatory guidance to US commercial teams, offering risk-based recommendations to support the planning and execution of marketing initiatives. Additionally, the role ensures that cross-functional advertising and promotion review teams operate effectively, follow established processes, and drive timely, compliant decision-making.
KEY RESPONSIBILITIES
- Lead and manage the US Materials Review processes (LMR & PARC), ensuring robust procedures for the creation, review, and approval of promotional, non-promotional, scientific exchange, and external communications that meet all regulatory requirements and support operational excellence.
- Ensure compliant review and approval of all professional and direct-to-consumer promotional and non-promotional materials for approved US products managed by Averitas.
- Oversee review of materials for investigational products, ensuring all US-facing materials adhere to FDA regulations and avoid any implication of pre-approval promotion.
- Build strong partnerships and collaborate effectively with cross-functional Medical, Legal, and other LMR team members to enable timely, aligned decision-making.
- Serve as the Subject Matter Expert on FDA advertising and promotion regulations, providing strategic guidance on promotional concepts, launch strategies, branding, campaigns, and materials for both approved and investigational products.
- Collaborate with Global Regulatory Affairs to ensure US promotional and sales training materials reflect current US prescribing information and align with global product strategy where appropriate.
- Act as the primary liaison to FDA's Office of Prescription Drug Promotion (OPDP), including oversight of FDA Form 2253 submissions for assigned products.
- Advise US Commercial teams on regulatory requirements and risk-based best practices to support compliant planning and execution of marketing strategies.
- Partner with Global Regulatory Affairs on the development, review, and approval of US labeling (e.g., carton/container labeling and US prescribing information).
- Ensure consistent application of regulatory standards across US Materials Review teams and verify adherence to established processes, documentation practices, and governance expectations.
- Represent US Commercial Regulatory in relevant cross-functional initiatives, including committees, training programs, and due diligence activities.
- Lead additional regulatory activities as assigned beyond advertising and promotion, contributing to broader regulatory initiatives as needed.
- Provides guidance and oversight to Regulatory Affairs team members and contractors as needed, fostering a collaborative, high-performance working environment grounded in regulatory excellence, trust, and proactive partnership.
- Partner cross-functionally to drive consistency, efficiency, quality, and compliance, providing clear, balanced regulatory risk assessments and facilitating productive risk-benefit discussions.
QUALIFICATIONS, CAREER EXPERIENCE AND SKILLS
A combination of relevant education and applicable job experience will be considered.
- Qualifications
- Bachelor's degree in scientific discipline; advanced degree preferred.
- A minimum of 7 years of Regulatory Affairs experience with a focus on US regulatory affairs, including advertising and promotional regulations.
- Strong verbal and written communication skills; able to engage and influence stakeholders at all levels, both internally and externally.
- Career Experience
- Direct experience engaging with FDA, preferably including interactions with the Office of Prescription Drug Promotion (OPDP).
- Developed and executed innovative regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction.
- Experience with labeling development and life-cycle management
- Extensive knowledge of US regulatory environment including FDA regulations, guidance documents, enforcement trends, and best practices related to advertising, promotion, and scientific exchange.
- Experience participating in or leading cross-functional materials review committees (LMR).
- Business Acumen
- Strong understanding of the competitive landscape, with the ability to monitor regulatory and promotional trends and translate insights into actionable US regulatory intelligence for commercial partners.
- Strong project management and negotiation skills.
- Ability to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities.
- Flexible, pragmatic, solution-oriented, independent and proactive working style.
- Strong ability to articulate regulatory rationale, influence cross-functional partners, and support balanced, compliant decision-making.
ETHICS AND COMPLIANCE
- Demonstrates the highest level of ethics, integrity, trust while acting with courage and candor.
- High accountability for your actions and results and ability to ensure a high level of commitment to the success of the organization, your peers and customers.
- Operates in compliance with all applicable regulations and professional standards at all times.
TRAVEL
- The ability to travel up to 15%, including overnights as dictated by business need and attend all company sponsored events/meetings/conferences.
VALUES & BEHAVIORS
- Live Entrepreneurship: Plan for long-term growth and build a future business predicated on innovation.
- Patient Centric: Deliver innovation for patients and challenge each other to improve patient outcomes.
- Join Forces: Seek diverse input, collaborate across all functions, and leverage resources from global partners.
- Act with Integrity: Apply ethical standards, encourage transparency, and embrace diversity and inclusivity.
- Drive Performance: Create an atmosphere that nurtures teamwork in order to enable high performance and sustainable growth.
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