Research Scientist-Global Regulatory New Product Development

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
November 06 2018
Ref
45832BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
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. 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 life cycle management; 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 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
  • Collaborate with New Product Value Analysis , Research and Development Teams, and Global Marketing to develop and maintain draft launch labels
  • Design and develop regulatory strategy and technical regulatory documents based on interpretation of both regulatory and scientific information
  • 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 draft launch labels 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
  • PhD and/or DVM with 2 years experience in regulatory industry or;
  • Master degree with 10 years experience in regulatory industry or;
  • Bachelor degree with 15 years experience in regulatory industry
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences
  • Background in food animal sciences.
  • Strong communication skills, both written and oral
  • Ability to make decisions when there is no clear right or wrong answer
  • Self-starter, takes initiative
  • Timeline driven
  • Attention to detail
  • Quality and customer focused mindset
  • Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time
  • Experience in clinical (GCP) or non-clinical (GLP) studies or regulatory affairs
    Experience in animal health product development
    Customer-based experience (sales)

Additional Information
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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