Job Description

Location: This role is remote in the United States with occasional travel to Sobi sites for business-critical meetings/events. Candidates on the US East coast prefered.

The Head of Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Compliance, Operations, Labeling and AdPromo (COLAP) and have accountability for 3 direct reports, the review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s), and be the owner of the Global Review Process (GRP).

The role is a core member of the COLAP LT. The role is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA and will be responsible to function as a leader during review and elevation meetings to assure compliance with and evolution of the applicable Review Committee (RC) 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 through the product life cycle assuring conformity with applicable laws, regulations and Sobi policies.

Key Responsibilities

Responsibilities include, but are not limited to, the following:

• Provides vision, strategy and leads the Regulatory Reviewers reporting into them
• Oversees and directs the Regulatory Reviewers in assessing regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents
• Demonstrates leadership as the Regulatory Advertising and Promotion Leader on the COLAP LT
• Business owner of the Global Review Process and provides Regulatory advice and guidance on Advertising and Promotion for Global Commercial and Medical materials
• Serve as an internal subject matter expert on FDA Advertising & Promotion issues for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations
• Provides regulatory training as needed on applicable laws, regulations and Sobi policies, and leadership on assigned RC with respect to best practices in compliance with company policies and guidelines for RC processes. Demonstrate leadership as the regulatory reviewer on RC(s)
• Develop SOPs and work instructions to facilitate streamlined workflows and encourage proficient practice of processes
• Manage interactions with OPDP/APLB, including response to regulatory inquiries, and as needed, discussion with OPDP/APLB staff
• Foster a healthy business partnership environment with stakeholders to ensure company meets strategic business objectives
• Lead SRC teams in management of tasks that help support compliant execution of tactics and programs through the product’s life-cycle

Qualifications

Education

• Minimum BS in scientific discipline
• Advanced scientific degree or Juris Doctor preferred

Experience

• 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

Core Competencies

• 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

Travel Requirements

Occasional travel for business-critical meetings/events.

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

The base salary pay range for this role is $230,000-$280,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

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.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. 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 toirina.conc@sobi.com

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.