Global CMC Regulatory Associate

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose

The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E) is accountable for the operational and technical CMC registration management processes that support the expedited delivery of safe and effective products to patients around the world. This is accomplished through a strong working knowledge of regulations related to CMC, guidance’s, and CMC regulatory precedence and collegial and mutually productive relationships across Lilly components, and partner companies.

The Global CMC Regulatory Associate utilizes CMC process expertise and CMC product specific knowledge to drive appropriate internal consistency and influence effective change management within GRA and cross-functionally. The scope of the work includes CMC records from the start of clinical trials through withdrawal of the marketing application.

The Associate works within regulations to expedite the registration and lifecycle maintenance of products. The Associate will triage and manage the communications between our Regional Submission Associates, GRA-CMC Scientists, RD&E Specialists, and the Quality/Reg Representatives. The Associate utilizes CMC submission process expertise and 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 RD&E specialists, and project management for marketed product support.

It is expected that this position embraces corporate transformation initiatives and represents GRA as a change ambassador.

Primary 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, 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 inquiries 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 Regional Submission Associate, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.
• Partner with Regional Submission Associate to align on submission strategies and timeline for deliverables and manage communications between Regional Submission Associate, GRA-CMC scientists, RD&E specialists and Quality/Regulatory representatives.

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 processes
• Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies

Minimum Qualification Requirements:

• Bachelor’s Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)
• Knowledge of pharmaceutical drug development or industry-related experience preferred.

Other Information/Additional Preferences:

• Drug development process or Industry-related experience
• Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.
• Ability to operate and manage operational requirements in a regulated environment
• Written, spoken and presentation skills
• Negotiation and influence skills
• Attention to detail and ability to effectively prioritize
• Proven effective teamwork skills; able to adapt to diverse interpersonal styles

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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