Associate Director, Regulatory Affairs AdPromo

Recordati; Bridgewater Township (NJ); Hybrid; USD 148,000 - 170,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision insurance

Mental health and wellness benefits

Paid time off and holidays

Winter holiday shutdown

Life and AD&D insurance

Weekly complimentary lunch on-site

Job summary

Recordati Rare Diseases North America seeks an Associate Director of Regulatory Affairs AdPromo to shape advertising and promotional regulatory strategy across North America. You will partner with commercial, medical, and legal teams to align messaging with FDA requirements while enabling business objectives.

The role requires deep expertise in ad/promo review, regulatory risk assessment, and leading cross-functional discussions to ensure compliant campaigns and timely submissions.

Qualifications

• Bachelor’s degree in science; advanced degree preferred.
• 10+ years in pharma with ad/promo review experience.
• Experience submitting to FDA.

Responsibilities

• Leads regulatory strategy and review for one or more therapeutic areas.
• Leads regulatory risk assessment discussions for promotional initiatives.
• Direct regulatory review of US/Canada materials directed to HCP, consumer, payor, and investor audiences.
• Ensures materials meet regulatory and company requirements.
• Reviews promotional materials to ensure compliance and timely review.
• Leads cross functional regulatory discussions and drives issue resolution.
• Mentors junior reviewers and cross-functional partners.

Skills

Regulatory strategy

FDA knowledge

Cross-functional leadership

Regulatory risk assessment

Promotional review

Project management

Communication skills

Veeva PromoMats

MS Office

eCTD knowledge

Education

Bachelor's degree

Advanced degree

Tools

Veeva PromoMats

MS Office

eCTD knowledge

PAAB familiarity

Job description

Associate Director, Regulatory Affairs AdPromo

ID: 2881

Date of Posting: Oct 9, 2026

Business Area: Regulatory Affairs

Job Type: Direct Employee

Territory: NA

Full-Time or Part-Time: Full Time

Seniority: Mid-senior

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

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 - 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 functionalstakeholders on compliant approaches.
• Direct regulatory review of US / Canadian commercial product and disease statematerials/communications directed to HCP, consumer, payor, and investor audiences across various media
• Provides regulatory oversight to ensure promotional materials meet applicable regulatory and companyrequirements
• Ensures timely review of materials to meet internal timelines, requirements, and compliance with approvedproduct 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 atimely manner (as per regulations and RRD timelines), collaborates with HQ submissions team, and ensuresmaterials 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 onthe Medical Review Committee (MRC)
• Maintains up-to-date knowledge of laws, regulations, and policies enforced by FDA as they relate toadvertising/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. Assessescompetitive 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 ortherapeutic areas.
• Serves as the primary regulatory partner to brand teams, advising on promotional strategy, messagingdevelopment, and risk mitigation.
• Leads complex regulatory discussions and provides authoritative interpretation of FDA advertising andpromotion 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 promotionalcompliance 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 promotionreview 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 documentsrelated 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 variousstakeholders
• 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 communicationskills
• 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 MSOffice (Outlook, Teams, Word, Excel, PowerPoint)
• Familiarity with eCTD requirements and e-submission formats/processes of promotional materials
• Demonstrated ability to manage multiple competing priorities

This job operates in a professional office environment. This role routinely uses standard office equipment such ascomputers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, the employee maybe required to attend meetings including travel out of state, over weekends, and nights. The employee must be able tofreely operate and travel by car and train/plane modes of transportation. The employee is required to have a means oftransportation

Physical Demands

The physical demands described here are representative of those required to successfully perform the essentialfunctions of this position. The employee must be able to travel domestically and internationally, as business needsrequire. This position is primarily sedentary. The employee may occasionally move throughout office, meeting, or eventlocations 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 travelpossible).

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 isthe 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 notdiscriminate 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

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.

Recordati Rare Diseases North America is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are not accepting new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees, or Human Resources. Recordati Rare Diseases North America will not pay fees to any third-party agency or firm associated with unsolicited resumes.

#LI-DV1

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.