Research Scientist-Companion Animal Global Regulatory New Product Development (NPD)

February 27 2018
Life Sciences
Position Type
Full Time
Organization Type
Job Type
Through the application of scientific training, regulatory acumen, and relevant experience, the Research Scientist will have a deep understanding of the overall pharmaceutical development process and be able to foster a molecule from a product concept through the development process to approval and data driven life cycle management (LCM) evolution for Safety and Efficacy (S&E). Specifically, the Research Scientist will: Take the lead role in developing the regulatory strategy for a product concept; critically evaluate both early and late phase data in support of product development; effectively work within a cross-functional team responsible for the creation, establishment, and delivery of an effective development program; develop and be responsible for the regulatory strategy in support of global product registration, commercialization, and LCM (S&E); lead discussions with external partners and/or customers to further refine regulatory strategies; drive submission execution to maintain compliance, meet the reporting requirements for the registration and approval of new animal drug / veterinary medicinal / specified feed additive applications, within optimal timelines and achieving business appropriate labels. Provide regulatory and technical overview of submissions (dossiers / non-CMC technical sections) pertaining to a product's approval.

The Research Scientist will also: Evaluate scientific information for potential molecule/product/ platform acquisition; participate and lead efforts within external organizations (e.g., IFAH, VICH, NOAH, AHI, AVMA, etc…) that support Elanco's business objectives; act as an internal technical and regulatory resource for existing products in support of business affiliates and Market Access / Government Affairs as well as globalization of these existing products.

Key Objectives/Deliverables
  • Comprehension of and contribution to scientific components (existing data and literature) and how it relates to regulatory strategy
  • Understand and evaluate a proposed product concept to provide the best possible product for the customer and increase Probability of Technical Success (PTS)
  • Collaborate with New Product Value Analysis (NPVA), Research and Development Teams, and Global Marketing to develop and maintain draft launch labels (DLL)
  • Prepare and maintain text based Mock labels to inform commercial labelling throughout the development process
  • Design and develop creative regulatory strategy (e.g., submission / regulatory plan) and technical regulatory documents (e.g., data H-Submissions, Innovation Task Force (ITF), Scientific Advice etc.) based on interpretation of both regulatory and scientific information
  • Lead compliant commercial label delivery during pre-launch phase across major geographies (EU/US)
  • Knowledge of and compliance with relevant laws and regulations, and global policies and procedures
  • Maintain a positive business collaboration and partnership with regulatory authorities
  • Serve as a resource to development teams and the commercial organization to actively address informational needs, including global and regional promotional material review.
  • Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers
  • Lead submission preparation to provide high quality submissions, reducing questions / hearings leading to optimal review times and speed to market
  • Maintain a level of competency of current scientific information through review of scientific literature as well as communications with industry key opinion leaders (KOLs)
  • Collaborate with development teams in the design, conduct and reporting of studies (both early and late stage development)
  • Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications
  • Collaborate on and review scientific documents including protocols and final reports to assure consistency with DLL and regulatory strategy
  • Participate in / contribute towards improvements in processes and procedures to deliver regulatory excellence in the new product development space

Company Overview
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana

Basic Qualifications
  • DVM degree
  • 3 years experience in clinical practice
  • 2 years experience in animal health industry

Additional Skills/Preferences
  • MBA or higher degree with DVM is preferred
  • Regulatory experience in the Animal Health industry or Competent Authority
  • Other regulatory educational experiences (classes, formal training, etc.)
  • Fluent English as a minimum

Additional Information
  • Some travel (up to 10% ) may be required
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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