Averitas Pharma · 4 hours ago
AD/Director Regulatory Affairs Advertising & Promotion, US
Morristown, NJ
Full-time
Hybrid
Director/Executive
$185K/yr - $240K/yr
7+ years expAveritas Pharma is a company focused on regulatory affairs in the pharmaceutical industry. They are seeking a US Regulatory Affairs Associate Director/Director to develop and execute regulatory strategies for advertising and promotional activities, ensuring compliance with FDA requirements and providing strategic guidance to commercial teams.
Pharmaceutical
Hiring Manager
Alina Begisheva
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
Qualification
Required
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
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
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
Ability to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities
Benefits
Annual performance bonus target of 20%/base salary (subject to meeting plan requirements)
Comprehensive health benefits (employer funded)
Unlimited vacation time
401k plan (subject to change or modification from time to time)
Company
Averitas Pharma
Averitas Pharma manufactures non-opiate pain agents for specialty pharmaceuticals.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2018-11-14Acquired
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