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Job Description
The Role of Regulatory Affairs Expert
Develop and execute US and Canada registration strategies to bring life-changing medicines to those who need them. At Lilly, we unite caring with discovery to make life better for people around the world. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.Key Responsibilities:
- Develop, update, and execute US and Canada registration strategies
- Assist or lead in the development of regulatory strategy by leveraging scientific, drug/device clinical development, and knowledge from FDA/HC meetings and regulatory trends
- Integrate information from the external environment, product-specific regulator advice, and other public information to develop robust, innovative regulatory strategies
- Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labeling
- Monitor upcoming and recent approvals of competitive development programs/plans
- Integrate US/CA regulatory strategy into global registration strategy
- Communicate and share key information to enable seamless execution of US/CA regulatory strategy
- Provide input to clinical program to support market differentiation needs
- Communicate regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignment
- Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets
- Collaborate with PRA and VEO for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning
- Support development and update of labeling strategy to deliver market differentiation
- Partner with regulatory, product, and clinical development, commercial, and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., Claims mapping)
- Develop and update US and CA labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indications
- Support the development of the US/Canadian labeling strategy in collaboration with Senior Regulatory Scientist and project personnel
- Support strategic development of US/CA labeling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labeling questions
- Apply labeling expertise, competitor knowledge, and regulatory precedent to propose labeling content to influence commercially viable labeling
- Support development of strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novo
- Determine and communicate submission and approval requirements and regulator expectations
- Generate regulatory documents for submissions
- Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate Lilly's scientific position
- Propose innovative solutions to regulatory and labeling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems
- Liaison with product and clinical development team and liaison with diagnostic development experts
- Provide high-quality, timely, and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development
- Cultivate relationships with development teams
- Liaison with global marketing/NPP/VEO/Payer functions/US Brand Teams
- Contribute to global and US launch-readiness plan and connect commercial partners (global marketing/NPP/VEO/Payer functions/US Brand Teams) with development teams to drive market differentiation strategy for assigned assets, including labeling and promotional deliverables throughout the product lifecycle
- Cultivate relationships with global marketing/NPP/VEO/Payer functions/US Brand Teams
- Own relationship and interaction strategy with US and Canada regulatory authorities
- Build, maintain, and leverage relationships with FDA, Health Canada, team members, and partner companies as appropriate
- Execute high-quality communications with FDA, Health Canada, and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues
- Accountable for communications to the regulator, development teams, and GRA, other development functions, Research, and BU leadership
- Advise/Approve US promotional strategy and claims
- Review corporate communications press releases and social media posts
- Set appropriate direction with Global Marketing and US Brand Team for development, review, and approval of promotional claims
- Partner with Regulatory Ad/Promo reviewer to advise US Brand Team on promotional strategy
- Partner with Regulatory Ad/Promo reviewer to review and approve press materials and IR communications
- Lead/Influence/Partner
- Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions
- Model the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers
- Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners
- Constructively challenge teams to reach the best solutions to issues
- Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions
Requirements:
- Bachelor's degree in scientific or health sciences discipline
- Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years
- Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable