Regulatory Advertising & Promotion Senior Manager…

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.