Averitas Pharma
Director, Regulatory Affairs Advertising & Promotion, US
MORRISTOWN, New Jersey · Director
Sponsorship not specifiedDetected 7 days ago
Product StrategyProject ManagementBrand StrategyNegotiationFDA RegulatoryCommunicationRegulatory Affairs
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About the role
- 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.
- 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.
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.
- 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.
- 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).
- Lead additional regulatory activities as assigned beyond advertising and promotion, contributing to broader regulatory initiatives as needed.
Requirements
- A minimum of 7 years of Regulatory Affairs experience with a focus on US regulatory affairs, including advertising and promotional regulations.
- Experience with labeling development and life-cycle management
- Experience participating in or leading cross-functional materials review committees (LMR).
- 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 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.
- Extensive knowledge of US regulatory environment including FDA regulations, guidance documents, enforcement trends, and best practices related to advertising, promotion, and scientific exchange.
- Business Acumen
- Strong project management and negotiation skills.
Nice to have
- Bachelor's degree in scientific discipline
- advanced degree preferred.
Compensation
- 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.
Benefits
- The company also currently offers a Long-Term Incentive Plan (cash plan) of 25% base salary, and annual performance bonus target of 25% base salary (subject to meeting plan requirements).
- Build strong partnerships and collaborate effectively with cross-functional Medical, Legal, and other LMR team members to enable timely, aligned decision‑making.
- Partner cross-functionally to drive consistency, efficiency, quality, and compliance, providing clear, balanced regulatory risk assessments and facilitating productive risk‑benefit discussions.
Company info
- 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.
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This listing is sourced directly from Averitas Pharma's careers page and normalized into a canonical job model.