Head of Global Regulatory Advertising and Promotion

Company Overview
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Competitive compensation for your work

Generous time off policy

Summer Fridays

Opportunity to broaden your horizons by attending popular conferences

Emphasis on work/life balance

Collaborative and team-oriented environment

Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description
The Head of Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Policy, Intelligence and Advertising & Promotion, be a core member of the GRA Extended Leadership Team (ELT), and have accountability for 6 or more direct reports. This role is responsible for leading and directing post‑marketing regulatory activities pertaining to marketing of Sobi products, including regulatory review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s), submission to FDA OPDP/APLB, and be the owner of the Sobi Global Material review process.

The role is responsible for leading interactions with the FDA Office of Product Prescription and Drug Promotion be responsible to function as a leader during review and escalation meetings to assure compliance with and evolution of the applicable Review process enabling business needs to be met in a compelling, compliant, and timely way.

This position requires frequent interaction and strong collaboration with cross‑functional partners for the purpose of providing regulatory advice and guidance throughout the product life cycle assuring conformity with applicable laws, regulations and Sobi policies.

Responsibilities

Provides vision, strategy and leads the ad‑promo team reporting into them

Develops and leads departmental strategic initiatives

Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation

Oversees and directs the ad‑promo team in assessing regulatory context and provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedents

Demonstrate leadership as the Regulatory Advertising and Promotion Leader

Business owner of the Global Review Process

Provides regulatory advice and guidance on Advertising and Promotion for Global promotional and non‑promotional materials

Serves as an internal subject matter expert on FDA Advertising & Promotion issues providing regulatory advice and offering solutions to regulatory concerns on draft promotional materials to ensure compliance with FDA regulations

Lead interactions with OPDP/APLB, including proactive engagement with OPDP/APLB in support of business needs, and as needed, response to regulatory inquiries.

Foster a healthy business partnership environment with cross‑functional stakeholders to ensure company meets strategic business objectives

Provides regulatory training as needed on applicable laws, regulations and Sobi policies

Demonstrate leadership as the regulatory reviewer on Review Committees (RCs)

Lead development of SOPs and Work Instructions to drive compliance through streamlined workflows and efficient execution of relevant processes

Education & Experience

Minimum BS in Scientific discipline

Advanced scientific degree (PhD, MD, PharmD, etc) or Juris Doctor preferred

Minimum of 15 years of experience in pharmaceutical industry and a minimum of 5 years as a regulatory Ad & Promo professional

Experience in Rare Diseases, Hematology and/or Oncology a plus

Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling

Advanced experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters

Skills, Knowledge & Languages

Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, product and therapeutic knowledge as well as evidentiary standards required to support product claims

Apply advanced regulatory experience and business knowledge in the development of new ideas and best practices that support Sobi

Advanced ability to spot issues and convey facts and risk mitigation strategies and guidance, including impact to Sobi without sufficient risk mitigation

Demonstrate understanding of company objectives while executing regulatory strategies that deliver efficacious and FDA‑compliant outcomes

Must reasonably foresee situations that are likely to be vague or challenging, and strategize to prevent or mitigate negative impact

Demonstrates the ability to build agreement and acceptance through the ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively

Efficiently and systematically plan, prioritize, and execute individual work, team work, and projects while balancing quality, cost, risk, and benefits

Proficient in the use of AI digital tools.

Occasional travel for Sobi business‑critical meetings/events.

Additional Information

Competitive 401(k) match to support your financial future.

Tuition and wellness reimbursements to invest in your personal and professional growth.

Comprehensive medical, dental, and vision package to prioritize your health and well‑being.

Additional recognition awards to celebrate your achievements.

The base salary range for this role is $260,000‑290,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short‑term and long‑term bonuses, as outlined in the plan details.

An Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to oririna.conc@sobi.com

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