Sr Dir, Global Reg Affairs, Advertising/Promotion Labeling

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.  

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI.  The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Senior Director, Global Regulatory Affairs, Advertising / Promotion and Labeling

This is a leadership position within regulatory affairs that requires, expertise in review of advertising and promotional material to ensure compliant advertising and comprehensive understanding of strategic global labeling from early development through life-cycle management. Responsibilities include supporting the development of global business and regulatory strategies and ensuring their successful implementation in all aspects of labeling, reviewing and approving the regulatory content of US materials prepared for product advertising, promotional and disease awareness communications. The incumbent will employ creative strategies and expertise in the review of promotional material, will act as the primary liaison with US FDA on regulatory issues and internal commercial and medical affairs teams pertaining to promotional materials. The role will also be responsible for labeling strategy, CCDS, establishing and overseeing the process for labeling, artwork, review of promotional materials through local partners and/or vendors. In addition, this position may oversee the monitoring, capture and sharing of Regulatory Intelligence and Policy information within Esperion.

Preferred Location: Remote – US 

Essential Duties and Responsibilities*

ADVERTISING AND PROMOTION

• Provide strategic regulatory guidance to cross functional Marketing, Medical Affairs, and Legal teams in the preparation of compliant advertising and promotional materials and other promotional communications. 
• Review and provide regulatory approval of US advertising, promotional and disease awareness materials to satisfy FDA regulations applicable to prescription drug advertising and promotion. 
• Serve as primary contact for communication with the US FDA Office of Prescription Drug Promotion (OPDP) for marketed products, including preparation and submission of advertising and promotional materials under cover of FDA Form 2253 and any other communications with OPDP related to advertising and promotional materials. 
• Provide oversight and direction through regional experts (vendors, partners, 3rd parties) to ensure requirements for ex-US promotional materials are satisfied according to local needs and guidelines. 
• Serve as the Regulatory Lead for the cross-functional internal review team (and external consultants/third party vendors) review of US advertising, promotional and disease awareness material utilizing the Veeva electronic document management system. 
• Maintain working knowledge of global regulatory promotional requirements and guidance, including industry practices and specific US FDA requirements and relevant FDA enforcement action and outcomes. 
• Actively contribute to the development and implementation of regulatory advertising and promotion training programs for cross-functional teams and partners. 

LABELING:

• Develops target product label, company core datasheet, patient labeling, USPI, and European SmPC, as well as acts as subject matter expert for other regional labels.
• Understands broad concepts within regulatory affairs and implications across organization. Proactively identifies labeling issues and offers creative solutions and strategies, including risk mitigation strategies.
• Keeps up to date on emerging clinical, product safety, and post-marketing data that may trigger changes to the company core datasheet and labeling.
• Manages labeling negotiations and drafts responses to Health Authorities queries. Guides/supports all labeling related negotiation meetings or teleconferences, as needed.
• Tracks health authority labeling requests and responses.
• Leads the development of labeling policies, procedures and SOPs.
• Provides strategic guidance regarding new and revised labeling regulations, competitor labeling, and labeling trends. 
• Works with the Graphic partners and internal stakeholders to create artwork for printed packaging components, ensuring labeling artwork and proofs meet all medical, legal and regulatory requirements.
• Oversees vendor activities related to projects within scope.

*additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• BS degree in scientific, clinical or related area required. Advanced degree highly desirable. Regulatory Affairs certification strongly preferred.
• 12+ years pharmaceutical/biotechnology industry experience with management experience with a minimum of 8 years in Regulatory Affairs 
• Proven track record of successful submissions to FDA and in-depth working knowledge of labeling and promotional material review. 
• Experience working with Veeva PromoMats Vault is a plus.
• Excellent leadership skills with ability to lead and influence cross functional teams focused on attaining company goals.
• Experience in interpreting regulations, guidelines, policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to labeling.
• Proven ability to foster effective, positive interactions with regulatory agencies and corporate partners and to effectively interface with the senior management team and regulatory agencies.
• Adaptability with small company lean-resourced mindset and roll-up-the sleeves management style for effectively working with peers and direct reports, which includes hands-on experience drafting regulatory documents and submissions with practical experience relevant to labeling.
• Well organized with exceptional communication skills, strong influencing skills, and a demonstrated ability to use constructive debate to identify and move others towards optimal outcomes.