Purpose
The Senior Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable for establishing the local regulatory strategy and plan for assigned product(s) in the region or country, ensuring the local plan aligns with the global regulatory strategy and incorporates local regulations and business needs. The role provides regional regulatory leadership and oversight for efficient regulatory submissions, approvals, and local labeling, leading meetings and interactions with region/country regulators.
Primary Responsibilities
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 labeling strategy (product information and packaging) and network for alignment across region/affiliate teams to enable timely completion of registration milestones (i.e. submission, approval, and launch). Apply labeling expertise, competitor knowledge, and regulatory precedent to propose labeling content to influence commercially viable labeling 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.
* Be involved in medical device/in‑vitro diagnostics regulatory activities and potentially serve as, or perform the responsibilities of, the medical device UK Responsible Person or EU Authorized Representative in accordance with applicable UK or EU legislation and the associated internal quality agreements.
* 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 to engage with relevant business units and development teams 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 the assigned region.
* Liaise with affiliates to anticipate region/country specific issues, impact of labeling 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
* Advanced scientific degree (i.e., PhD, MD, PharmD) or bachelor’s with significant relevant industry‑related experience in regulatory affairs and/or drug development.
* Industry‑related experience in regulatory affairs and/or drug development.
* Knowledge of local/regional regulatory procedures and practices.
* Awareness of evolving regulatory reform initiatives (preferred).
* 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 embracing diversity, equity and inclusion 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.
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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