Head of Global Regulatory Advertising & Promotion

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

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 (O