Senior Director Regulatory Affairs, Advertising & Promotion

Join Immatics and shape the future of cancer immunotherapy; one patient at a time! Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment. Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy.Collaborative Culture: Be part of a diverse team dedicated to your professional growth.Global Impact: Contribute to therapies that make a lasting impact on patients globally.We are seeking a Senior Director Regulatory Affairs, Advertising & Promotion to lead U.S. regulatory strategy for promotional materials across Immatics' pipeline and future product launches. This role chairs the PRC, manages OPDP/APLB interactions, supports labelling negotiations, and ensures promotional content complies with FDA regulations. The position partners closely with Legal, Marketing, Medical Affairs, and Pharmacovigilance. FLSA Classification: Salary, Exempt Schedule: 8:00 AM - 5:00 PM; Monday to Friday; On-site or Remote Reports to: Global Head of Regulatory Affairs Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 What You'll Do: As a Senior Director, you will play a key role in supporting our Regulatory Operations: Strategic Regulatory Leadership Chair and lead 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 labelling, and OPDP guidance.Labelling & FDA Liaison Prepare and file pre-clearance materials via Form FDA 2253, lead OPDP interactions, and respond to enforcement letters/advisories.Support label negotiations for PI, carton/container, and PPI.Promotional Compliance Oversight Review advertising copy, promotional claims, speaker programs, digital/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 (for Senior Director level) Mentor junior RA professionals; oversee operational delivery and resource allocation.Manage budget for Ad/Promo activities and ensure cohesive execution across programs. Secondary Functions: Develop, author, maintains, and has accountability for SOPs, is accountable for toolkit processes (e.g., using Veeva PromoMats), and leads continuous improvement in processesCollaborate on governance and policy development for new media platforms and emerging promotional channels (e.g., social media and AI-generated content)Develop and deliver training on Ad/Promo requirements (PDMA, PhRMA Code, scientific exchange, AE/PQ reporting obligations).Monitor OPDP enforcement trends, legal rulings, and regulatory changes.Required Experience and Education: Bachelor's in Life Sciences, Pharmacy, Regulatory Affairs;Minimum of 10 years in pharma/biotech Regulatory Affairs with 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.Strong understanding of AE/PQ reporting, promotional review, and recall protocols.Experience using tools like Veeva PromoMats; process optimization mindset.Preferred Experience and Education: Advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, Regulatory AffairsRA Certification (RAC)Knowledge of global promotional regulations would be a plus.Competencies: InitiativeProblem SolvingExceptional judgement, communication, and cross-functional collaboration.Work Environment: Most likely remote position. If on site, this is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected. Travel required: Occasional domestic or international travel. Physical demands: Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).Pushing - Exerting force upon an object so that the object moves away from the object.Pulling - Exerting force upon an object so that the object moves toward the force.Sitting - remaining in a sitting position for at least 50% of the time.Standing/Walking - remain on one's feet in an upright position at a workstation.Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.Work authorization/security clearance requirements : Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment. Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.Sick Time Off - 56 hours12 Paid Holidays100% Employer-Paid Life Insurance up to at 1x annual salary100% Employer Paid Short- and Long-Term Disability Coverage401(k) with Immediate Eligibility & company match...You are eligible for 401(k) plan participation as of your first paycheck.The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.Partially paid Parental Leave for eligible employees. (3 weeks)Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy.Company provided learning and development opportunitiesFast paced, high demand collaborative and dynamic environment.