Eli Lilly and Company

Sr Associate-Global Regulatory Affairs

Location
Greenfield, IN, United States
Posted
Dec 06, 2018
Ref
44971
Required Education
Bachelors Degree
Position Type
Full time
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.

Responsibilities
The primary purpose of the Global Regulatory Affairs, CMC position is to provide Regulatory support and expertise for Elanco's Marketed Product portfolio. The Consultant will be responsible for managing aspects associated with the US Annual Reports within mandated timelines, including document collection, compilation, review/approval and submission. The Consultant will also be responsible for evaluating and modifying the Annual Reporting process, as necessary, from a continuous improvement perspective. The role may also be assigned to special projects, aimed at driving organizational improvements and efficiency.

Functions, Duties, Tasks:
  • Manage aspects associated with US Annual Report activities (maintain schedule, collect documents, compile draft reports, coordinate review/approval/submission activities with key subject matter experts, etc.)
  • Ensure the required documentation and any content, quality and/or timelines for Annual Report submissions are communicated to the appropriate teams and tracked accordingly
  • Evaluate and modify the US Annual Reporting process (including any associated functional procedures), as necessary
  • Maintain a positive collaboration and partnership with internal groups in Regulatory, Quality, Manufacturing, North American Area Group and GRS, among other key contact
  • Facilitate and/or maintain a positive collaboration and partnership with the US CVM
  • Represent Global CMC Regulatory on cross-functional teams, as assigned
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions, as applicable
44971BR

Basic Qualifications
Bachelor's Degree with 3 years experience in regulatory.

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
  • Fundamental knowledge of US regulations
  • Strong communication skills, both written and oral
  • 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
  • Must be able to speak and to write in English
  • Familiarity with the chemistry, manufacturing and control components of a registration dossier
  • Understanding of global regulatory requirements (US, EU, CA, etc.)
  • Familiarity with Regulatory Authoring and Archival Tools (RAPID, ELRRTS and EDMS)


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.