Director, Regulatory Affairs - Advertising and Promotional Compliance

i-Pharm Consulting; Boston (MA); Vor Ort; USD 225.000 - 250.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Vision insurance

401(k)

Zusammenfassung

A leading consulting firm in Boston is seeking a Director of Regulatory Affairs to oversee U.S. promotional review compliance. This role requires strong leadership and communication skills, along with extensive knowledge of FDA regulations. The position offers competitive compensation, with a salary range of $225,000 to $250,000, and the opportunity to influence strategy within a collaborative culture.

Qualifikationen

• 5+ years of U.S. regulatory advertising & promotion experience in pharmaceuticals or biotech.
• Experience with marketed products and pipeline promotional review; launch experience preferred.
• Broad therapeutic area experience; rare disease, oncology, neuroscience, metabolic or bone preferred.

Aufgaben

• Serve as the Therapeutic Area Lead and primary Regulatory Affairs representative.
• Review and approve U.S. promotional materials for compliance with FDA regulations.
• Act as the point of contact with the FDA, managing regulatory interactions.

Kenntnisse

Leadership presence

Strong communication skills

Ability to influence without authority

Collaborative mindset

Knowledge of FDA promotional regulations

Understanding of OPDP interactions

Ausbildung

Bachelor’s degree

Advanced scientific degree

Jobbeschreibung

Overview

We are seeking an experienced Director of Regulatory Affairs – Advertising & Promotion to 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/yr

Key Responsibilities

• Serve as the Therapeutic Area Lead and primary Regulatory Affairs representative for 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 degree required and advanced scientific degree preferred
• 5+ years of U.S. regulatory advertising & promotion experience in the pharmaceutical or biotech industry.
• Proven expertise in OPDP 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 bone experience 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)