Associate/Senior Associate/Manager – Global CMC Regulatory, Regulatory Delivery and Excellence
Eli Lilly and Company
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $63,000 - $149,600 per year
Job Level
About the role
- Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including an extensive knowledge of ICH CTD and evolving global agency standards
- 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
- 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
- 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
Requirements
- Bachelor’s Degree preferably in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)
- 2+ years of experience in pharmaceutical drug development
- 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
Benefits
- 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
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC regulatory requirementsICH CTDsubmission managementpharmaceutical drug developmentproject managementsubmission proceduresemerging submission electronic standardstechnical reportsmanufacturing changeslife-cycle management
Soft Skills
problem-solvingcommunicationnegotiationinfluenceattention to detailprioritizationteamworkadaptabilityopen discussionsguidance
Certifications
Bachelor’s Degree in scientific or health sciences