Regulatory Advertising & Promotion Senior Manager (North America)

Company Description

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

Job Description

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. 
   

Qualifications

Education 

• Minimum BS in scientific d