Senior Director Regulatory Affairs, Advertising & Promotion

Role Overview

We are seeking a Senior Director, Regulatory Affairs Advertising & Promotion to support our Regulatory Affairs team. The Senior Director will serve as the primary U.S. regulatory expert for promotional materials through Immatics’ pipeline and any future commercial launches.
Basic Qualifications

Bachelor's in Life Sciences, Pharmacy, or Regulatory Affairs
12+ years in pharma or biotech Regulatory Affairs with an Advertising/Promotion focus including leadership responsibility
Proven expertise in FDA‑regulated promotional compliance, COP/OPDP, and PI/label negotiations
Comprehensive knowledge of FDCA, OPDP, FDAMA, PDMA, PhRMA Code, scientific exchange, misbranding, and fair balance
Preferred Qualifications

Advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, or Regulatory Affairs
RA Certification (RAC)
Knowledge of global promotional regulations (preferred)
In this Role You Will

Strategic Regulatory Leadership: Chair and lead the PRC, ensuring fair balance, alignment with Prescribing Information (PI), and compliance with scientific exchange and misbranding rules
Ensure U.S. advertising and promotional strategy consistency with FDCA, FDAMA, FD&C labeling, and OPDP guidance
Labelling & FDA liaison: Prepare and file pre‑clearance materials via Form FDA 2253, lead OPDP interactions, and respond to enforcement letters and advisories
Support label negotiations for PI, carton and container, and PPI
Promotional Compliance Oversight: Review advertising copy, promotional claims, speaker programs, digital and social media materials, and HCP‑facing promotions for FDA compliance; identify and remediate claims, manage recall and mitigation activities when necessary
Team Leadership & Budget Management: Mentor junior RA professionals; oversee operational delivery and resource allocation; manage the budget for Ad/Promo activities and ensure cohesive execution across programs
Travel Required

Occasional domestic or international travel.
Benefits

Health, dental, and vision insurance at competitive rates
Four weeks of vacation granted up front each year, prorated for the first and last year of employment
Twelve paid company holidays
Seven days of sick time
100% employer‑paid life insurance up to one year’s salary, up to one hundred thousand dollars
100% employer‑paid short‑ and long‑term disability coverage
401(k) with company match: 100% match up to 3% of base salary for the first two years, 4% for years two to three, and up to 5% from the fourth year onward
Partially paid parental leave for eligible employees
Additional voluntary employee‑paid benefits and services such as accident insurance, hospital indemnity, critical illness insurance, identity theft protection, and pet insurance
Equal Employment Opportunity

We are an equal‑opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law.
Reasonable Accommodations

We are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances.
Work Authorization

Applicants must be authorized to work in the United States without the need for current or future sponsorship. Visa sponsorships may be available for certain roles.
Pre‑Employment Requirements

Employment is contingent upon successful completion of a background check, reference checks, and pre‑employment drug screening, where permitted by applicable law. For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job‑related and consistent with business necessity.

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