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

The Regional Regulatory Scientist in Global Regulatory Affairs (GRA) Intercontinental Hub (APAC/AMETA/LATAM) 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 role provides regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling for assigned product(s) and leads meetings and other interactions with region/country regulators. The role may perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in the regulatory area.

Responsibilities

Establish the local regulatory strategy and plan for assigned product(s) in region/country and ensure alignment with the global regulatory strategy; Provide regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling; Lead meetings and other interactions with region/country regulators; Provide region/country input and review of global strategic plans and global/regional submission plan and documents; Ensure approval and delivery of content for local regulatory submissions; Own relationship and lead meetings and interactions with regulators in assigned region; Lead development of local/regional labelling strategy; 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; Own all regulatory activities in support of assigned marketed product(s) in the region/country; Ensure local regulatory requirements in APAC/AMETA/LATAM countries are communicated to development and CMC teams; Ensure registration needs for local patients in clinical trials are met; Partner with Global Regulatory Leads on regulatory and submission sequencing strategy; Liaise with affiliates to anticipate region/country specific issues; Serve as a mentor for GRA personnel; Propose continuous improvement projects to simplify processes

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; 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

Nice to have

Awareness of evolving regulatory reform initiatives; Local language proficiency is desirable dependent on region