Global Regulatory Affairs Lead, Product Communications

BioSpace; Indianapolis (IN); On-site; USD 132,000 - 194,000; Full time

Job summary

Lilly in Indianapolis, IN seeks an Associate Director, Global Regulatory Affairs - Product Communications to lead and influence regulatory communications for promotional assets. You will partner with Regulatory Scientists, brand teams, and FDA OPDP to ensure compliant messaging and strategic promotion.

The role emphasizes high-quality regulatory advice, cross-functional collaboration, and risk mitigation in a fast-paced environment.

Qualifications

• Bachelor's Degree required.
• 3+ years of industry-related experience in drug development and/or commercialization.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas.

Responsibilities

• Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics, internal field-based communications, medical affairs communications, and campaign tactics for media events
• Provide high quality, prompt and conclusive regulatory advice that enables business partners to make well-informed decisions
• Communicate regulator expectations by utilizing OPDP feedback, interpreting laws, regulations and guidances, and knowledge of FDA enforcement actions
• Contribute to risk mitigation by following trends related to advertising, promotion and medical communication topics
• Build, maintain, and utilize relationships with Lilly team members and partner companies to influence communications
• Initiate promotional tactic discontinuation plans for Regulatory-initiated events
• Counsel internal partners on OPDP advisory strategy; collaborate with marketing and ad agencies on promotional proposals, and provide quality review of submission documents
• Partner with US brand team to interpret OPDP advice and support interactions with OPDP
• Provide timely and quality review of 2253 promotional material submissions to FDA
• Engage US Regulatory Scientist in development and analysis of promotional claims and review of press materials and IR communications
• Lead labeling revisions to balance business implications with regulatory compliance
• Communicate and share key information to enable seamless execution of US regulatory strategy and promotional activity
• Engage in forums that share regulatory information across the organization and partners
• Challenge teams to reach the best solutions and foster open discussions to reach robust business decisions

Skills

Regulatory affairs

Influence without authority

Strategic communications

FDA regulations

Cross-functional collaboration

Advertising/promotional review

Project management

Education

Bachelor's Degree

Job description

Lilly in Indianapolis, IN seeks an Associate Director, Global Regulatory Affairs - Product Communications to lead and influence regulatory communications for promotional assets. You will partner with Regulatory Scientists, brand teams, and FDA OPDP to ensure compliant messaging and strategic promotion.

The role emphasizes high-quality regulatory advice, cross-functional collaboration, and risk mitigation in a fast-paced environment.