Advertising & Promotion Manager, Regulatory Affairs

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.

Reporting Structure

Reports To: Director, Regulatory Affairs Advertisement, Promotion and Labeling 
Direct Report(s): None
Areas Managed: Advertisement/Promotion and Labeling, North America
 

Overview

This role is responsible for supporting regulatory review and activities related to advertising/promotion of our marketed pharmaceutical products and devices. This role requires an understanding of regulatory frameworks, strategic thinking, and the ability to navigate complex regulatory compliance requirements.

Essential Duties and Responsibilities

•    Provide review of US product and disease state materials/communications 
•    Ensure promotional labeling meets regulatory and company requirements
•    Ensure timely review of AdPromo materials to meet internal timelines, requirements, and in compliance with current approved labeling
•    Submits product promotional material to OPDP on Form FDA 2253 in a timely manner as per regulations, and that materials are archived per company policy
•    Coordinate cross-functionally to resolve regulatory issues that impact promotional activities
•    Assist, liaise with FDA Office of Prescription Drug Promotion (OPDP) for company products
•    Maintain up-to-date knowledge of laws, regulations and policies enforced by FDA as they relate to advertising/promotion of pharmaceuticals products
•    Handle additional duties and special projects, as assigned by the VP of Regulatory Affairs
•    Continually assess AdPromo-related processes to enhance efficiency and compliance
•    Provide insights and guidance across multiple functional areas, on the development of product messages and materials
•    Monitor competitor advertising to keep abreast of market promotional and advertising strategies. Assess competitive materials for potential violations
•    Monitor untitled and warning letters to keep abreast of competitive promotional and advertising practices, and assess potential impact
•    Review concepts, materials, and communications used in scientific exchanges; represent Regulatory on the Medical Review Committee (MRC)
 

Education and Experience

•    Bachelor’s degree and 5+ years of relevant pharmaceutical industry experience with 4+ years of relevant Regulatory Affairs advertising, promotion and labeling experience
•    Experience preparing and submitting regulatory documentation to FDA
•    Experience preferred in Rare Diseases, as well as Oncology, Biologics & Devices
 

Knowledge and Skills

•    Working knowledge of applicable laws, regulations, and guidance related to AdPromo
•    Solid understanding of the structure and function of product labeling
•    Strong interpersonal and communication skills, organizational skills and attention to detail
•    Proficiency and strong experience with MS Office (Outlook, Teams, Word, Excel, PowerPoint), Veeva PromoMats, and Adobe Acrobat
•    Familiarity with eCTD requirements and e-submission formats/processes 
•    Demonstrated ability to manage multiple competing priorities
•    Ability to conduct independent review of materials and tactics with minimum supervision required
 

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 at times 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 valid driver’s license and means of transportation.
 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location

•    This position is based at RRD’s headquarters in 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.

EEO Statement

Recordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin.  Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, provincial, or municipal law.  Recordati Rare Diseases will provide reasonable accommodation for qualified individuals with disabilities.  

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.