Eli Lilly

GRA Regulatory Delivery Excellence, Clinical Regulatory Associate

Eli Lilly • $63K — $149K *
US-AnywhereRemote in Indianapolis, IN
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS or higher in chemistry, biology, pharmacy, or related field
  • 3 years of regulatory operations experience in a regulated environment
  • Experience with CTD/eCTD structure and format
  • Familiarity with eCTD compliant publishing systems like eCTDXpress or Veeva
  • Strong knowledge of global health authority and ICH regulations

Responsibilities

  • Lead registration management processes ensuring compliance with submission regulations
  • Partner with global teams to align on electronic submission regulations
  • Guide development teams on registration management processes
  • Own molecule/project level registration, ensuring accuracy and timeliness
  • Serve as operational lead in registration planning and execution
  • Maintain routine compliance submissions and processes
  • Provide registration expertise for due diligence and business development

Benefits

  • Comprehensive benefits program including medical, dental, and vision
  • 401(k) and pension plan participation
  • Eligible for company bonuses based on performance
  • Flexible spending accounts for healthcare and dependent care
  • Wellness benefits including employee assistance programs and fitness incentives
Full Job Description
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


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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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