Head of Global Regulatory Advertising and Promotion
About The Position
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
Requirements
- Minimum BS in Scientific discipline
- Minimum of 15 years of experience in pharmaceutical industry and a minimum of 5 years as a regulatory Ad & Promo professional
- 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
- 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
- Demonstrate 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
- Proficient in the use of AI digital tools.
- Occasional travel for Sobi business-critical meetings/events.
Nice To Haves
- Advanced scientific degree (PhD, MD, PharmD, etc) or Juris Doctor preferred
- Experience in Rare Diseases, Hematology and/or Oncology a plus
Responsibilities
- Lead and direct post-marketing regulatory activities pertaining to marketing of Sobi products
- Regulatory review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s)
- Submission to FDA OPDP/APLB
- Owner of the Sobi Global Material review process
- Lead interactions with the FDA Office of Product Prescription and Drug Promotion
- Function as a leader during review and escalation meetings to assure compliance with and evolution of the applicable Review process
- Provide regulatory advice and guidance throughout the product life cycle assuring conformity with applicable laws, regulations and Sobi policies
- Provide vision, strategy and leads the adpromo team reporting into them
- Develop and lead departmental strategic initiatives
- Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation
- Oversee and direct 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
- Provide regulatory advice and guidance on Advertising and Promotion for Global promotional and non-promotional materials
- Serve 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
- Provide 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
Benefits
- 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
- A competitive 401(k) match to support your financial future.
- Tuition and wellness reimbursements to invest in your personal and professional growth.
- A comprehensive medical, dental, and vision package to prioritize your health and well-being.
- Additional recognition awards to celebrate your achievements.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
