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The purpose of this position is to provide regulatory support to facilitate registrations of nutritional health innovation products and product life-cycle management with a focus on APAC and non-EU EMEA. The Consultant works with the GRINH Team, Manufacturing, global Regulatory Affairs Managers, and, as needed, Research & Development teams, to facilitate delivery of high quality submissions for the registration activities in targeted countries.
The Consultant works closely with the global Affiliates to understand the regulatory requirements for making specific registration changes (e.g., new species, new manufacturing site, new production strain) and then the Consultant will develop or identify how to obtain certificates and will develop International Summary Dossiers to support new product submissions as well as existing product variations/line extensions. The Consultant often interfaces with the Global Regulatory Operations team as regards Affiliate requests. This role educates and advises, as needed, on matters relevant to Nutritional Health Regulatory topics based on their training and using support from the Team Advisor or Senior Director.
Functions, Duties, Tasks:
- Work collaboratively, effectively and flexible within and across all Elanco teams and external collaborators to achieve overall Elanco deliverables
- Provide guidance in the development of regulatory strategies within product development teams for targeted countries in APAC and non-EU-EMEA
- Effectively coordinate resources to support the execution of submissions through Global Regulatory Managers in APAC and non-EU-EMEA
- Manage project timelines and provide information to facilitate accurate project time
- Deliver high quality and approvable technical data to the local Affiliates for local formatting into approvable submissions
- Understand the technical aspects and science of new products entering the NH business pipeline
- Develop knowledge of the regulatory requirements for NH products in the required countries in APCA and non-EU-EMEA. Help local Affiliates to shape the regulatory landscape to enable faster submissions and approvals for target countries
- Engage with Global Regulatory Managers to respond to requests and questions from regulatory agencies
- Over time to develop scientific, regulatory and analytical skills to be able to effectively support Regulatory innovation initiatives.
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor’s Degree in life science-related field
- 3 years of Regulatory affairs experience
- Master’s Degree in science related field
- Experience in Veterinary or Animal Science
- Understanding of the Animal Nutrition Industry and the Feed Additive development process
- Worker Type for this role may be Fixed, Flexible or Teleworker
- Additional Work Locations may be anywhere globally. Preferred locations are US, EMEA and APAC
Elanco 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