Director, Regulatory Affairs - Advertising and Promotional Compliance

ipharm consultingEast Boston, MAyesterday

$225,000 per year

Occupations

Regulatory Affairs Managers Advertising and Promotions Managers Regulatory Affairs Specialists

Industries

Research and Development in Biotechnology (except Nanobiotechnology)Pharmaceutical Preparation Manufacturing Other Services Related to Advertising

Overview: We are seeking an experienced Director of Regulatory Affairs – Advertising & Promotionto serve as a Therapeutic Area Lead and regulatory representative for U.S. promotional review. This individual will oversee compliance of promotional materials with FDA regulations, act as the primary point of contact with the FDA’s Office of Prescription Drug Promotion (OPDP), and partner closely with cross‑functional business stakeholders. While this is an individual contributor role, the Director will have oversight and final approval authority for assigned products, managing reviewers within their therapeutic area. This position offers the opportunity to lead a therapeutic area and contribute to shaping strategy, with potential to progress into a more senior leadership position in the future. Location

Location: Boston, MA (Onsite 3 days/week - you choose what days)

Compensation Base pay range$225,000.00/yr - $250,000.00/yrKey Responsibilities Serve as the Therapeutic Area Leadand primary Regulatory Affairs representativefor assigned products. Review and approve U.S. promotional materials for compliance with FDA regulations, including OPDP requirements. Act as the point of contact with the FDA, managing regulatory interactions and submissions as needed. Partner with Marketing, Legal, Medical Affairs, and other business stakeholders to ensure compliant and effective promotional strategies. Lead and support the development, maintenance, and implementation of relevant SOPs. Provide ad/promo compliance guidance and training across the business. Maintain up-to-date knowledge of industry trends, evolving FDA guidance, and global promotional regulations. Oversee the work of promotional reviewers within your therapeutic area, ensuring quality and compliance of output.

Qualifications: Bachelor’s degreerequired and advanced scientific degree preferred 5+ years of U.S. regulatory advertising & promotion experiencein the pharmaceutical or biotech industry. Proven expertise inOPDP interactions, FDA promotional regulations, and global ad/promo standards. Strong leadership presence with the ability to influence without direct authority. Exceptional communication skills, with the ability to have constructive yet tough conversations, defend positions, and remain flexible when appropriate. Collaborative mindset with the ability to build strong, trust-based relationships and find common ground. Broad therapeutic area experience; rare disease, oncology, neuroscience, metabolic, or boneexperience preferred but not required. Experience with both marketed products and pipeline promotional review; launch experience a plus. Culture Culture: Company culture values setting employees up for success and fostering collaborative, solutions-oriented working relationships. Apply Apply below if this sounds like you! Details

Seniority level: Director

Employment type: Full-time

Job function: Science

Industries: Pharmaceutical Manufacturing and Biotechnology Research

Benefits: Medical insurance Vision insurance 401(k)

Apply now

Level

ManagerL7

Salary

$225,000 per year

Location

East Boston, MA

Occupation

Regulatory Affairs Managers

Industry

Research and Development in Biotechnology (except Nanobiotechnology)

Posted

yesterday

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