Senior Director-Global Regulatory Affairs - Global Regulatory Scientist

Lilly • Indianapolis, IN

5d • $169,500 - $248,600 • Onsite

About The Position

The Senior Director, Global Regulatory Affairs (GRA), Global Regulatory Scientist (GRS) is accountable to establish and execute the US regulatory strategy and plan for assigned product(s), ensure the local plan aligns to the global regulatory strategy and Global Regulatory Plans (GRP), and ensure US regulatory requirements and business needs are included. This role operates within a dual-accountability structure: the GRS reports solid-line to the Senior Director – GRA Global Regulatory (M3 or P5) or LRL@Cork Global Regulatory Scientist Leader (M2) for people management, career development, and capacity planning, and maintains a dotted-line relationship with the assigned Global Regulatory Lead (GRL) for all job content, scientific direction, and FDA strategy execution. The specific reporting configuration is determined by the TA Leader, who may establish parallel technical or coaching structures for senior GRSs.
The Senior Director, GRS is accountable to provide regulatory leadership and oversight in delivering high quality and efficient regulatory submissions, approvals, and labelling for their assigned product(s) in the United States. The Senior Director is responsible for leading and/or participating in meetings and other interactions with FDA and supports the assigned GRL in the development and implementation of Global Regulatory Plans across the assigned portfolio.
Differentiation of the GRL and the GRS role: the GRL holds sole, global accountability for regulatory strategy; the GRS provides deep U.S./FDA scientific and technical expertise in support of that strategy. Demonstrated scientific/technical depth in the therapeutic area, global regulatory strategic thinking and the ability to influence and represent regulatory positions credibly at a senior level including with global regulatory authorities are the key differentiators that position a Global Regulatory Scientist for future consideration as a Global Regulatory Lead.

Requirements

• Advanced scientific degree (i.e., PhD, MD, PharmD) with at least 5 years, OR Bachelor’s with at least 10 years, of relevant industry-related experience in regulatory affairs and/or drug development
• Knowledge of local/regional regulatory procedures and practices
• Demonstrated knowledge of the integrated drug development process and Lilly’s (or external peer company) regulatory/business strategies
• Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Strong written, spoken and presentation communication
• Demonstrated negotiation and influence skills
• Demonstrated attention to detail

Nice To Haves

• Awareness of evolving regulatory reform initiatives
• Industry-related experience in regulatory affairs and/or drug development experience for 8 years
• May be named as a lead for lower-complexity assets (near-end-of-development lifecycle) and/or NILEX programs, providing an additional growth pathway toward Global Regulatory Lead readiness

Responsibilities

• Advise and assist the assigned GRL in the execution of the global regulatory strategy for product(s) in the US, ensuring scientific quality, strategic coherence, and alignment with the Global Regulatory Plan.
• Provide oversight of the preparation, review, and timely delivery of regulatory submission content (INDs, NDAs, BLAs, supplements, responses) in coordination with the GRL and cross-functional teams. Ensure strategic messaging and scientific quality of all submission documents.
• Lead and/or participate in FDA meetings and interactions; own relationship and interaction strategy with FDA for assigned product(s). Serve as a senior scientific resource for meeting preparation, briefing document development, and agency negotiation strategies in coordination with the assigned GRL.
• Define the scientific priorities and key deliverables for assigned program(s) by providing senior-level regulatory input and scientific review of Global Regulatory Plans (GRP) and global/regional submission plans and documents. Contribute during key governance committees on regulatory strategy decisions that impact the US.
• Lead development of labelling strategy for assigned product(s), applying deep regulatory expertise, competitor intelligence, and regulatory precedent to propose labelling content. Lead team during negotiation with FDA under GRL direction, providing responses to labeling questions and influencing commercially viable labelling outcomes.
• Provide up-to-date expertise on US regulatory procedures, guidelines, and evolving reform initiatives. Interpret and anticipate the impact of new guidelines and initiate change in response to the changing regulatory environment. Communicate impacts to the GRL and cross-functional teams.
• Ensure compliance with all applicable US regulations and internal quality systems for assigned product(s). Provide regulatory oversight and quality assurance for submission-related deliverables.
• Own all regulatory activities in support of assigned marketed product(s) in the US. Perform regulatory evaluations of external business opportunities as requested by management and effectively manage alliance/CRO relationships in the regulatory area.
• Set appropriate direction with Global Marketing and US Brand Team for development, review, and approval of promotional claims in coordination with GRA-Product Communications.
• Partner with GRA-Product Communications reviewer to advise US Brand Team on promotional strategy
• Partner with the assigned GRL in the development and implementation of Global Regulatory Plans, providing senior scientific expertise and ensuring robust regulatory strategies are executed for assigned product(s) in the US.
• Maintain a dotted-line working relationship with the assigned GRL: recommend and receive strategic direction, scientific priorities, and FDA content guidance from the GRL; lead execution with autonomy and senior judgment within the defined scope. Ensure effective linkages between GRS regulatory activities and the broader global regulatory strategy.
• Advocate for effective information sharing between the GRS and GRL organizations; proactively share regulatory intelligence, FDA feedback, and submission status to maintain a consistent and shared operational picture. Anticipate regulatory risks and propose mitigation strategies to the assigned GRL.
• Partner with the GRL to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for the US. Provide senior scientific input into global regulatory strategy formulation and drive a consistent focus on achieving high standards for regulatory capabilities.
• Participate in forums that share regulatory information across GRL and GRS organizations, and other Lilly teams and business partners. Contribute to cross-functional regulatory governance forums and ensure alignment between GRS activities and the broader global regulatory strategy.
• Assess GRS organizational performance by executing feedback processes with the GRL and business partners. Serve as the named interface point for the assigned TA when designated, providing strategic counsel to the GRL on complex regulatory matters and ensuring continuous improvement of GRS-GRL ways of working.
• Partner with Global Regulatory Leads and other global regulatory team members to help solve and deliver on development and regulatory issues impacting submissions and registrations, engaging with relevant business unit and development teams on assigned programs/products.
• Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.
• Propose continuous improvement projects to simplify processes and increase productivity of regulatory work.
• Lead or represent the regulatory function on cross-functional non-product related projects. Promote a culture that fosters innovation and seeks to continually improve regulatory excellence and operational excellence.
• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
• Model innovation, leadership behaviours, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Constructively challenge teams to reach the best solutions to issues.
• Recruit, manage, train, develop, and coach a complementary team
• Responsible for the supervision, organization, and performance management of direct reports.
• Manage resources by monitoring workload to assure balanced and maximum efficiency of individual talent and capacity.
• Motivate and inspire by identifying what is important to employees; reward and recognize appropriately.
• Set high expectations for value creation, monitor performance, and take appropriate action.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior