Global Head Ad Promo

The Head of Global Regulatory Affairs - Advertising and Promotion is responsible for leading and overseeing the regulatory strategy and compliance of promotional and non-promotional materials globally. This executive role ensures that all advertising, promotional, and external communications activities comply with applicable regulations, guidelines, and company policies. The incumbent will provide leadership across regions (e.g., U.S., EU, APAC, LATAM) and collaborate with cross-functional partners including Marketing, Legal, Medical Affairs, and Commercial to drive compliant and innovative messaging that satisfies regulatory requirements while meeting strategic corporate and business objectives.

Main Responsibilities & Accountabilities

•Strategic Leadership:
Provide US/global oversight, leadership and direction to develop and execute US and global regulatory ad/promo strategies to support product commercialization, lifecycle management, and expansion into new markets.

•Regulatory Review & Compliance:
Oversee the review and approval process for promotional and non-promotional materials (e.g., websites, social media, HCP/patient brochures, press releases) for consistency with local and international regulatory requirements (e.g., FDA, EMA, PMDA).

•Regulatory Authority Interaction:
Serve as the primary point of contact with regulatory bodies on advertising and promotion matters, including submission of materials to FDA OPDP or APLB, responding to inquiries, and managing enforcement risk.

•Cross-functional Collaboration:
Partner with Legal, Compliance, Medical, and Commercial teams to ensure accurate and balanced content in alignment with product labeling and company strategy.

•Policy and SOP Development:
Lead the development and implementation of global policies, standard operating procedures (SOPs), and training programs for advertising and promotional review processes.

•Team Leadership:
Build and manage a high-performing global regulatory ad/promo team of reviewers. Provide mentorship, professional development, and performance management.

•Risk Assessment:
Identify and mitigate regulatory risks in promotional materials and campaigns. Provide guidance during concept development and campaign planning phases.

•Innovation Enablement:
Support the integration of digital and emerging media in advertising strategies while maintaining compliance.

Qualifications & Experience Requirements

•Advanced degree (PharmD, PhD, MD, JD, or equivalent) preferred; Bachelor's degree required.

•12+ years of Regulatory Affairs experience, with at least 8+ years specifically in advertising and promotion within the pharmaceutical, biotechnology, or healthcare industry.

•In-depth knowledge of global regulatory requirements and guidances (e.g., FDA OPDP, EMA, Health Canada).

•Experience with regulatory submissions for promotional materials (e.g., Form 2253, 2254) and advisory comments from OPDP/APLB.

•Proven leadership skills in managing teams, projects, and cross-functional collaborations.

•Exceptional communication, negotiation, and decision-making skills.

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what's available to you as a CSL employee.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.