Global CMC Regulatory Associate, Regulatory Delivery Excellence

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Organization Overview

The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE) leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Associate also partners with GRA-CMC Scientists to help create and manage RIM/Leo/Regulus submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions. The Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidance’s, and regulatory precedence. The Associate will triage and manage the communications between our Lilly Affiliates, GRA-CMC Scientists, Specialists, and the Quality/ Reg Representatives. The Associate utilizes GRA-CMC submission process expertise and their expertise with Information Technology tools to develop project management expectations across projects. Based on implementation and supply chain needs within manufacturing, the Associate will be responsible for routine communication of submission tracking requirements to both GRA-CMC Scientists and internal customers. The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support.

Responsibilities

Regulatory & Drug Development Expertise

Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.Responsible for triage of Lilly affiliate inquires and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.Implement and in some cases interpret global regulations and guidance’s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Lilly affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.

Lead, Influence, Partner

Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processesDemonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies

Basic Requirements

Bachelor’s Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)Minimum of 2 years previous regulatory submission experience.

Additional Skills/Preferences

Drug development process or Industry-related experienceKnowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.Ability to operate and manage operational requirements in a regulated environmentWritten, spoken and presentation skillsNegotiation and influence skillsAttention to detail and ability to effectively prioritizeProven effective teamwork skills; able to adapt to diverse interpersonal styles

Additional Information

Travel less than 5%

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