Associate Director, Regulatory Affairs Advertising and Promotion

Regulatory Affairs Advertising Promotion Specialist

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati. 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.

Reporting Structure Reports To: Director, Regulatory Affairs - Advertising, Promotion, and Labeling Direct Report(s): None Areas Managed: Advertising & Promotion North America

Overview This role is responsible for supporting regulatory review and activities related to advertising / promotion of our marketed pharmaceutical products in 1 or 2 of the following therapeutic areas: oncology, endocrinology, hematology. This role requires an understanding of regulatory frameworks, strategic thinking, and the ability to navigate complex regulatory compliance requirements.

Essential Duties and 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

Education and Experience

• Bachelor's degree required and preferred in a science discipline (e.g. biology); 8+ years of relevant pharmaceutical industry and 4 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, 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

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 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 handle or feel; and reach with hands and arms; talk and hear. Occasionally required to lift and/or move light to moderate weight (up to 25 lbs).

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.

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.

Disclosures

Annualized Pay Range (Base Pay): $137,600 - $180,000 Other Types of Pay: Annual bonus 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.