Associate Director/ Director - Global Regulatory Scientist

GRA Regulatory Science and FDA Execution Responsibilities

• Support and assist the assigned GRL in the execution of the global regulatory strategy for product(s) in the US, ensuring scientific quality and alignment with the Global Regulatory Plan.
• Prepare, review, and ensure timely delivery of regulatory submission content (INDs, NDAs, BLAs, supplements, responses) in coordination with the GRL and cross-functional teams. Ensure 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 scientific resource for meeting preparation, briefing document development, and agency negotiation strategies in coordination with the assigned GRL.
• Provide 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.
• Apply regulatory expertise, competitor intelligence, and regulatory precedent to support labelling strategy for assigned product(s). Participate in negotiations with FDA under GRL direction, providing responses to labelling questions and supporting 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).
• Own all regulatory activities in support of assigned marketed product(s) in the US. May perform regulatory evaluations of external business opportunities as requested by management and may effectively manage alliance/CRO relationships in regulatory areas.
• 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.

Support Global Regulatory Plan Development and Implementation

• Partner with the assigned GRL in the development and implementation of Global Regulatory Plans, providing regulatory expertise and ensuring robust regulatory strategies are delivered 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; complete with autonomy within that defined scope. Ensure effective linkages between GRS regulatory activities and the broader global regulatory strategy.
• Proactively share regulatory intelligence, FDA feedback, and submission status with the assigned GRL to maintain a consistent and shared operational picture. Anticipate regulatory risks and communicate them to the assigned GRL.
• Partner with the GRL to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and driven for the US. Provide regulatory input into global regulatory strategy and drive a consistent focus on achieving high standards for regulatory capabilities.
• Participate in forums that share regulatory information across GRL and GRS organisations, 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.
• Serve as the named interface point for the assigned TA when designated, collaborating closely between GRL strategy and GRS execution, and supporting continuous improvement of GRS-GRL ways of working.

Operational Excellence

• 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.
• 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 develops innovation and seeks to continually improve regulatory excellence and operational excellence.
• Serve as a mentor for GRA personnel.
• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
• Model innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Constructively challenge teams to reach the best solutions to issues.
• Create and lead in an environment of equity and inclusion that encourages open discussions to achieve robust business decisions.

Select, Develop, and Retain Talent (if applicable)

• Responsible for the supervision, organization, and performance management of direct reports, if applicable.
• Motivate and inspire by identifying what is important to employees; reward and recognize appropriately.

Minimum Qualification Requirements:

• Bachelor’s degree in scientific or health sciences discipline
• Industry-related experience in regulatory affairs and/or drug development experience for minimum of 2 years
• Knowledge of FDA and local/regional regulatory procedures and practices
• Awareness of evolving regulatory reform initiatives
• Demonstrated knowledge of the drug development process, Lilly’s (or external peer company) regulatory/business strategies
• Ability to identify solutions and alternatives through collaborative teamwork, embracing diversity, equity, and inclusion to achieve positive business outcomes
• Ability to assess and manage risk in a highly regulated environment
• Strong written, verbal, and presentation communication skills
• Effective negotiation and influencing skills
• Strong attention to detail

Other Information/Additional Preferences:

• Industry-related experience in regulatory affairs and/or drug development experience for 5 years (preferred)
• Location: preferably in the region of support; preferably at a Lilly/LRL site
• Key Contacts: project team members, Global Regulatory Lead and other global regulatory team members, regional marketing/medical, and affiliate regulatory representatives

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