Senior Director, Regulatory Affairs – Advertising & Promotion

This is a fully remote position, open to applicants in Texas.

📋 Description

• Act as the primary Regulatory expert for U.S. promotional materials associated with Immatics’ pipeline and any upcoming commercial launches.

• Lead and chair the PRC, ensuring "fair balance," alignment with Prescribing Information (PI), and adherence to scientific exchange and misbranding regulations.

• Ensure that U.S. advertising and promotional strategies are consistent with FDCA, FDAMA, FD&C labeling, and OPDP guidance.

• Prepare and submit pre-clearance materials using Form FDA 2253, manage OPDP interactions, and address enforcement letters and advisories.

• Assist in label negotiations for PI, carton/container, and PPI.

• Review advertising copy, promotional claims, speaker programs, digital/social media content, and HCP-facing promotions for FDA compliance.

• Identify and rectify claims, managing recall and mitigation activities when necessary.

• Mentor junior Regulatory Affairs professionals; oversee operational delivery and resource management.

• Manage the budget for advertising and promotional activities, ensuring cohesive execution across all programs.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or Regulatory Affairs.

• 12+ years of experience in pharma/biotech Regulatory Affairs with a focus on Advertising/Promotion, including leadership responsibilities.

• Demonstrated expertise in FDA-regulated promotional compliance, COP/OPDP, and PI/label negotiations.

• Extensive knowledge of FDCA, OPDP, FDAMA, PDMA, PhRMA Code, scientific exchange, misbranding, and fair balance principles.

• An advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, or Regulatory Affairs is preferred.

• Regulatory Affairs Certification (RAC) is required.

• Familiarity with global promotional regulations would be advantageous.

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• 4 weeks of vacation granted upfront each year, prorated for the first and last year of employment.

• 12 company-paid holidays.

• 7 days of sick leave.

• 100% employer-paid life insurance up to 1x annual salary, capped at one hundred thousand dollars.

• 100% employer-paid short- and long-term disability coverage.

• 401(k) plan with immediate eligibility and company matching.

• Partially paid parental leave for eligible employees.

• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, along with identity theft protection and pet insurance.