Associate Director/ Director - Global Regulatory Scientist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life'

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

This is a 12-month Fixed Term Contract

Purpose:

The Associate Director / 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 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, and may serve in GRL capacity for NILEX programs.

The Associate Director / Director, GRS is accountable to provide regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and labelling for their assigned product(s) in the United States. The Associate Director / Director leads and/or participate 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.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any role/position can change over time and can include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position.

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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