Associate Director, Regulatory Affairs Advertising and Promotion

Recordati • Bridgewater, NJ

6d • 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 rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Requirements

• Bachelor’s degree required and preferred in a science discipline (e.g. biology)
• 8+ years of relevant pharmaceutical industry
• 4 years of direct advertising and promotion review experience
• Experience preparing and submitting regulatory documentation to FDA
• Thorough understanding of applicable laws, regulations, and FDA guidance related to ad/promo
• 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

Responsibilities

• Direct regulatory review of US / Canadian commercial product and disease state materials/communications
• Ensures promotional materials meet ad/promo regulatory and company requirements
• Ensures timely review of materials to meet internal timelines, requirements, and compliance with approved product labels
• Submits product promotional material to OPDP (Office of Prescription and Drug Promotion) on Form FDA 2253 in a timely manner as per regulations, and ensures materials are archived per company policy. Responsible for preparation of communications to the FDA
• Coordinates cross-functionally and drives to resolution issues that impact promotional activities
• Provides insights and guidance to multiple functional areas on the development of product messages, assets, programs, tactics, etc.
• 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

Benefits

• Health Insurance: Medical, dental, orthodontia, vision, life & ADD, short and long-term disability insurance benefits.
• Retirement Benefits: 401k
• Paid Time Off: Vacation, holiday, and sick/personal time.

What This Job Offers

• Job Type: Full-time
• Career Level: Director