Organization Overview: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/Sr. Associate/Manager works within regulations to expedite the registration and lifecycle maintenance of products. They will prioritize 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 encouraged that this position embraces corporate transformation initiatives and represents GRA as a change ambassador.
Responsibilities:Regulatory & Drug Development Expertise- Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including an extensive 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 GRA-CMC Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
- Partner with the GRA-CMC 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 GRA-CMC 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- Develop 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
Basic Requirements:- Bachelor's Degree preferably in a scientific or health sciences field (e.g., pharmacy, chemistry, or related scientific subject area)
- 2+ years of experience in pharmaceutical drug development
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Additional Skills/Preferences:- 1+ year of experience using Veeva RIM
- 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
- Experience managing projects
- Attention to detail and ability to effectively prioritize
- Proven effective teamwork skills; able to adapt to diverse interpersonal styles
Additional Information:
• Travel less than 5%
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $149,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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