Regulatory Advertising & Promotion Senior Manager (North America) - Sobi

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

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.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• 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

The NA Regulatory Advertising and Promotion Senior Manager will report to the Head of Global Regulatory Advertising & Promotion. As a voting member of the Review Committee, the regulatory representative will assess materials for regulatory context and provide regulatory interpretations of applicable guidance and/or regulations, or regulatory precedents including requirements related to the submission of Material to the OPDP/FDA. The Review Committee supports Sobi’s commitment to excellence in advertisements and promotions while carefully considering Sobi’s corporate and specific brand objectives. 

This position requires frequent interaction and collaboration with cross-functional partners for the purpose of providing regulatory advice and guidance through the brand lifecycle assuring conformity with applicable laws, regulations and Sobi policies. These consultations will occur within and beyond the established review meetings. 

This role is remote with occasional travel to Sobi sites for business-critical meetings/events. 

Sobi is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the lives of rare disease patients and their families.  Key areas of focus included inflammation and genetic diseases.  We have world-class capabilities in protein biochemistry and biologics manufacturing development – validated by leading industry partners. We are part of an organization covering over 30 countries in Europe, Middle East, Asia, Australia and North America. 

Preferred candidates live on the US East coast.

Key Responsibilities 

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

• Specialized knowledge on regulations and requirements governing product promotion and related communications in the US, including pipeline and disease state communications. 

• Responsible for guiding the regulatory efforts for assigned product(s) on Sobi Review Committee (SRC) and Medical Review Committee (MRC) and is the Regulatory representative on additional relevant programs and other cross-functional teams as needed. 

• In collaboration with Medical, Legal and Commercial, provides regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications. 

• As a regulatory reviewer, assesses the regulatory context and provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to regulatory bodies and interactions with regulatory bodies, as needed. 

• Provides guidance and input for development products reflective of promotional considerations, including assessment of potential labeling claims. 

• Provides training to Commercial and other groups on US laws, codes and regulations related to drug advertising and promotion and updates as they become known. 

• Monitors the external environment to advise product teams on evolving regulatory requirements related to advertising and promotion to support successful and compliant marketing of Sobi products and assesses impact. 

• Provides direction and works collaboratively to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements. 

• Collaborates in cross-functional efforts to develop and update procedures and guidelines related to internal review processes. 

• Plans and conducts training sessions as needed with stakeholders. 
   

Education 

• Minimum BS in scientific discipline 

• Advanced scientific degree preferred. 

Experience 

• Minimum of 2-3 years of experience in pharmaceutical industry and a minimum of 2 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. 

• Experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters.  

• General understanding of clinical study design and statistical analyses in assessment of promotional claims. 

• Strong interpersonal and communication skills with the ability lead without direct authority. 

• Ability to creatively innovate, analyze, and solve problems. 

• Pharmaceutical industry and regulatory advertising and promotion experience, including interacting with US and Canada regulatory agencies. 

• Experience with DTC broadcast ads and digital tactics highly desirable. 

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.  

• Demonstrated 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. 

• Experience with electronic review systems 

Travel Requirements 

Occasional travel for business-critical meetings/events. 

The base salary pay range for this role is $133,000-$180,000 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. 

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.

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 to irina.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.