Head of Global Regulatory Advertising and 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 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 Head of Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Policy, Intelligence and Advertising & Promotion, be a core member of the GRA Extended Leadership Team (ELT), and have accountability for 6 or more direct reports.  This role is responsible for leading and directing post-marketing regulatory activities pertaining to marketing of Sobi products, including regulatory review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s), submission to FDA OPDP/APLB, and be the owner of the Sobi Global Material review process.

The role is responsible for leading interactions with the FDA Office of Product Prescription and Drug Promotion be responsible to function as a leader during review and escalation meetings to assure compliance with and evolution of the applicable Review 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 throughout the product life cycle assuring conformity with applicable laws, regulations and Sobi policies.

• Provides vision, strategy and leads the adpromo team reporting into them
• Develops and leads departmental strategic initiatives
• Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation
• Oversees and directs the adpromo team in assessing regulatory context and provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedents
• Demonstrate leadership as the Regulatory Advertising and Promotion Leader
• Business owner of the Global Review Process
• Provides regulatory advice and guidance on Advertising and Promotion for Global promotional and non-promotional materials
• Serves as an internal subject matter expert on FDA Advertising & Promotion issues providing regulatory advice and offering solutions to regulatory concerns on draft promotional materials to ensure compliance with FDA regulations
• Lead interactions with OPDP/APLB, including proactive engagement with OPDP/APLB in support of business needs, and as needed, response to regulatory inquiries.
• Foster a healthy business partnership environment with cross-functional stakeholders to ensure company meets strategic business objectives
• Provides regulatory training as needed on applicable laws, regulations and Sobi policies
• Demonstrate leadership as the regulatory reviewer on Review Committees (RCs)
• Lead development of SOPs and Work Instructions to drive compliance through streamlined workflows and efficient execution of relevant processes

Qualifications

Education/Learning Experience/Work Experience

Required:  Minimum BS in Scientific discipline

Desired:  Advanced scientific degree (PhD, MD, PharmD, etc) or Juris Doctor preferred

• 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

Skills/Knowledge/Languages

Required: 

• Advanced understanding of FDA promotional regulations, industry trends, regulatory landscap