This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.
Reporting Structure
Reports To: Director, Regulatory Affairs - Advertising, Promotion, and Labeling
Direct Report(s): None
Areas Managed: Advertising & Promotion North America
Overview
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
Essential Duties and 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
Long Education and Experience
• 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
• Experience preferred in rare diseases
Knowledge and Skills
• 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
• Familiarity with Canada's Pharmaceutical Advertising Advisory Board (PAAB) Code a plus
• 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
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, the employee may be required to attend meetings including travel out of state, over weekends, and nights. The employee must be able to freely operate and travel by car and train/plane modes of transportation. The employee is required to have a means of transportation
Physical Demands
The physical demands described here are representative of those required to successfully perform the essential functions of this position. The employee must be able to travel domestically and internationally, as business needs require. This position is primarily sedentary. The employee may occasionally move throughout office, meeting, or event locations and regularly operate a computer, telephone, and other office productivity equipment.
The employee must be able to communicate effectively with internal and external stakeholders. Occasionally, the employee may be required to move or transport items weighing up to 25 pounds, with or without accommodations.
Location
• This position is based at RRD's headquarters in Bridgewater, New Jersey.
• This position requires up to 20% of travel. Ability to travel within US/Canada (and some additional, limited EU travel possible).
FLSA Classification
This position is considered Exempt.
Disclaimer
The expected salary range for this role is $148,000 - $170,000, depending on skills, competency, and market demand for your expertise.
In addition to base salary, compensation at Recordati Rare Diseases North America includes an annual bonus, along with a comprehensive benefits program that includes:
• 401(k) plan with a 100% company match on contributions up to 6%
• Medical, dental, and vision insurance
• Mental health and wellness benefits
• Generous paid time off and holiday policies
• Weeklong winter holiday shutdown
• Life and AD&D insurance
• Weekly complimentary lunch when on-site
We also offer additional programs that support your health, wellbeing, and work-life balance.
