Associate Director/Director/Senior Director-Regulatory Scientist, Global Regulatory Affairs Intercontinental Hub – APAC/AMETA/LATAM Full-time

Associate Director/Director/Senior Director, Global Regulatory Affairs (GRA) Intercontinental Hub (APAC/AMETA/LATAM) Regional 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.

Purpose:

The Associate Director/Director/Senior Director, Global Regulatory Affairs (GRA) Intercontinental Hub (APAC/AMETA/LATAM) Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included.

The Associate Director/Director/Senior Director, GRA Intercontinental Hub (APAC/AMETA/LATAM) Regional Regulatory Scientist is accountable to provide regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). The Associate Director/Director is responsible for leading meetings and other interactions with region/country regulators.

The Associate Director/Executive Director, GRA Intercontinental Hub (APAC/AMETA/LATAM) Regional Regulatory Scientist may perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.

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 position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory Expertise for Assigned Program/Product(s) in Region/Country

• Provide region/country input and review of global strategic plans and global/regional submission plan and documents.
• Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region).
• Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content.

• Own relationship and lead meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Influence the regulator in favor of the planned development.

• Lead development of local/regional labelling strategy (product information and packaging) and network for alignment across region/affiliate team to enable timely completion of registration milestones (i.e. submission, approval, and launch). Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country. Lead team during negotiation with regulators by providing responses to labeling questions.
• Ensure compliance with all applicable regulations and internal quality systems.
• Provide up-to-date expertise on regional registration procedures.
• Interpret and anticipate impact of new guidelines and initiate change in response to changing environment.
• Own all regulatory activities in support of assigned marketed product(s) in the region/country.

For regional regulatory scientist supporting APAC/AMETA/LATAM:

• Ensure the local regulatory requirements in APAC/AMETA/LATAM countries are communicated to development and CMC teams for incorporation into molecule development programs
• Ensure the registration needs for local patients in clinical trials are met for countries in the region/country

Lead, Influence and Partner

• Partner with Global Regulatory Leads to help solve development and regulatory issues impacting local registrations and when engaging with relevant business unit and development team on assigned programs/products.
• Partner with Global Regulatory Leads to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries in assigned region.
• Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing, and reimbursement.
• Participate in regional meetings (commercial managers, medical directors) to ensure that regulatory strategy and issues are considered and to learn about their needs.
• 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 work executed by affiliates and GRA
• Lead or represent the regulatory function on cross-functional non-product related projects
• Serve as a mentor for GRA personnel.

• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
• Model the 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 on issues to achieve a robust outcome on business decisions.

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 5 years
• Knowledge of local/regional regulatory procedures and practices
• Awareness of evolving regulatory reform initiatives, preferred
• Demonstrated knowledge of the drug development process, Lilly's (or external peer company) regulatory/business strategies
• Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Demonstrated strong written, spoken and presentation communication
• Demonstrated negotiation and influence skills
• Demonstrated attention to detail

Other Information/Additional Preferences:

• Key Contacts: Project team members, Global Regulatory Leads and other global regulatory team members, regional marketing/medical, and affiliate regulatory representatives
• Local language proficiency is desirable dependent on region.
• Location: preferably in the region of support; preferably at a Lilly/LRL site

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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.