GRA Regulatory Delivery Excellence, Clinical Regulatory Associate

Lilly • Indianapolis, IN

5d • $63,000 - $149,600 • Onsite

About The Position

The Global Clinical Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE), is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients. This is accomplished through a strong working knowledge of regulations, guidance’s and regulatory precedence and collegial and mutually productive relationships across Lilly components, partner companies, and within relevant ministries of health. The Associate uses process expertise and therapeutic area knowledge to drive appropriate internal consistency and influence effective change management within GRA and cross-functionally. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embraces corporate transformation initiatives and represents GRA as a change ambassador.

Requirements

• BS or higher degree in a technical field such as chemistry, biology, pharmacy or life sciences
• 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 and 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
• Three years of regulatory operations experience within a regulated environment with experience and knowledge in formatting and publishing medium/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical).
• Experience with Original IND and supplemental NDA/BLA eCTD submissions including complex lifecycle submissions.
• Strong knowledge of global health authority and ICH regulations and guidance as it pertains to format and submission structure.
• Current knowledge of CBER/CDER regulatory technical requirements
• Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness
• Experience with document management and Regulatory Information Management Systems (RIM)
• Broad technical knowledge (MS Word, Adobe Acrobat PDF Bookmarks and Hyperlinks, Acrobat Plug-ins, Document Management Systems, Excel, ISI Toolbox, Lorenz)
• The individual must be able to maintain the security of confidential information

Nice To Haves

• Knowledge of drug development process
• Project Management Experience
• Previous experience working in the Pharmaceutical industry
• Experience with CTD/eCTD structure and format.
• Experience using eCTD compliant publishing system (eCTDXpress or Veeva based platforms)

Responsibilities

• Provide Regulatory & Drug Development Expertise
• Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content. This includes but is not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD.
• Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification
• Guide and influence development team and function regarding internal and Agency registration management processes and requirements
• Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate. Records include IND and NDA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact
• Serve as the RDE operational lead for registration planning and execution including but not limited to critical chain planning sessions and status updates, team operation meetings and RDE planning.
• Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions.
• Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
• Provide registration management expertise to the due diligence and business development processes.
• Serve as the registration management expert for other processes dependent upon the registration record (e.g. OSI requests, out-license, user fees/drug listing/orange book)
• Lead/Influence/Partner
• Develop collaborative relationships with personnel in other Lilly functional areas (e.g. medical, legal, labeling, compliance, quality, affiliates, etc.) to effectively influence the electronic registration plan.
• Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutions.
• Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review
• Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings.
• Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise.
• Influence others in a manner that builds maximum advantage for the organization.
• Communicate verbally and in writing to effectively influence within work group/function and with development team
• Serve as a mentor within GRA

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level