Associate Director, Regulatory Affairs AdPromo

Recordati•Bridgewater, NJ

31d•$148,000 - $170,000•Onsite

About The Position

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati. Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives. This role serves as a senior regulatory affairs partner responsible for shaping advertising and promotional regulatory strategy for marketed products across one or more therapeutic areas. The Associate Director provides strategic guidance to commercial, medical, and legal stakeholders to ensure promotional initiatives align with regulatory expectations while enabling business objectives. The role serves as a key regulatory voice within cross functional teams and may act as the regulatory lead for assigned products or portfolios. It requires a deep understanding of regulatory frameworks, strategic thinking, and the ability to navigate complex regulatory compliance requirements.

Requirements

Bachelor’s degree required and preferred in a science discipline; advanced degree preferred.
10+ years of relevant pharmaceutical industry experience, including 6+ years of direct advertising and promotion review experience.
Experience preparing and submitting regulatory documentation to FDA
Thorough understanding of applicable laws, regulations (mainly 21 CFR 202), and FDA guidance documents related to ad/promo and scientific exchange (for example CFL guidance, SIUU guidance)
Demonstrated ability to influence cross functional stakeholders and senior leadership.
Strong regulatory risk assessment and decision making capabilities.
Ability to balance regulatory compliance with business strategy.
Ability to interpret compliance letters to industry and to explain their relevance to RRD’s portfolio to various stakeholders
Demonstrated ability to conduct independent review of materials and tactics
Demonstrated record of functional representation on committees, strong interpersonal and communication skills
Solid understanding of the structure and function of product labeling
Strong organizational skills and attention to detail
Proficiency reviewing and annotating in Veeva PromoMats (or comparable system) and experience with MS Office (Outlook, Teams, Word, Excel, PowerPoint)
Familiarity with eCTD requirements and e-submission formats/processes of promotional materials
Demonstrated ability to manage multiple competing priorities

Nice To Haves

Experience preferred in rare diseases
Familiarity with Canada’s Pharmaceutical Advertising Advisory Board (PAAB) Code a plus

Responsibilities

Leads regulatory strategy and review for one or more therapeutic areas
Leads regulatory risk assessment discussions for promotional initiatives and advises cross functional stakeholders on compliant approaches.
Direct regulatory review of US / Canadian commercial product and disease state materials/communications directed to HCP, consumer, payor, and investor audiences across various media
Provides regulatory oversight to ensure promotional materials meet applicable regulatory and company requirements
Ensures timely review of materials to meet internal timelines, requirements, and compliance with approved product labels
Leads cross functional regulatory discussions and drives to resolution issues that impact promotional activities; drives for reconciliation of regulatory compliance with messaging goals and other reviewer (Legal, Medical) perspectives
Provides insights and guidance to multiple functional areas on the development of product messages, assets, programs, tactics, etc.
Prepares promotional material binders for submission to OPDP (Office of Prescription and Drug Promotion) in a timely manner (as per regulations and RRD timelines), collaborates with HQ submissions team, and ensures materials are archived per company policy. Responsible for preparation of communications to the FDA
Reviews concepts, materials, and communications used in scientific exchanges; represents Regulatory Affairs on the Medical Review Committee (MRC)
Maintains up-to-date knowledge of laws, regulations, and policies enforced by FDA as they relate to advertising/promotion of pharmaceuticals products
Handles additional duties and special projects, as assigned by the Director of RA Ad/Promo
Continually assesses ad/promo-related processes to enhance efficiency and compliance
Monitors competitor advertising to keep abreast of market promotional and advertising strategies. Assesses competitive materials for potential violations
Monitors OPDP enforcement actions and assesses potential learnings / impact.
Provides strategic regulatory leadership on advertising and promotional initiatives across assigned brands or therapeutic areas.
Serves as the primary regulatory partner to brand teams, advising on promotional strategy, messaging development, and risk mitigation.
Leads complex regulatory discussions and provides authoritative interpretation of FDA advertising and promotion guidance.
Advises senior commercial and medical leadership on regulatory risk associated with promotional initiatives.
May act as the regulatory lead for launch planning and campaign initiatives.
Provides mentorship and guidance to junior regulatory reviewers and cross functional partners on promotional compliance expectations.
Leads or contributes to the development of internal advertising and promotion policies, standards, and training.
Serves as an escalation point for complex promotional review issues