GRA Regulatory Delivery Excellence, Clinical Regulatory Associate

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Purpose:

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.

Primary 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 us 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

Minimum 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 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 Preferences:

• Knowledge of drug development process
• Project Management Experience
• Previous experience working in the Pharmaceutical industry

The following skills and abilities are directly related to the essential functions of the job.

• Experience with CTD/eCTD structure and format.
• Experience using eCTD compliant publishing system (eCTDXpress or Veeva based platforms)
• 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

Computer Skills:

• 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

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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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