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Responsible for leading and managing the Elanco US animal nutritional health (NH) regulatory activities (including CMC, Innovation, Maintenance), and advising, as needed, on global regulatory matters.
Responsible to interface effectively with the NH R&D Team, and other functional areas including PVS&T, TS/MS, Manufacturing, Quality, and Supply Chain.
The overarching goals are to ensure that high quality regulatory submissions are produced to meet the expectations of the US regulatory authorities and our NH business customers, and that Elanco is compliant with US regulations
Proactively search for solutions to regulatory problems.
Work effectively and flexibly within and across Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables.
Create a positive work environment that is aligned with company objectives.
Deliver innovative technical solutions and create an innovative culture
Identify and use methods to deliver individual objectives in a high quality, timely, cost-effective manner
Provide information to facilitate accurate and timely project and budget forecasts.
Manage project timeline and budget deliverables to facilitate delivery of the Elanco pipeline.
Anticipate market access obstacles and strive to resolve barriers by working in a team environment
Thorough knowledge of US regulations and guidelines that impact new animal product development.
Maintain a positive business collaboration with US regulatory authorities (federal and state) and as needed assist both colleagues and global regulatory affiliates in interactions with OUS regulatory authorities.
Oversee the design/development/implementation of US regulatory strategy.
Conduct, coordinate, and/or supervise regulatory activities as necessary.
Collaborate with a multi-functional team that delivers submissions and strategy within project timelines.
Author appropriate SOPs and policies as needed.
Ensure that US regulations are met.
Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
Key Performance Indicators (KPIs):
KPIs for an Advisor in this role measuring progress and performance are aligned and set in accordance with:
Organizational objectives and goals
Departmental / Team objectives and goals
Individual objectives identified during Performance Management Process
Education and Experience:
BS, Chemistry, Biochemistry, Animal Science, or equivalent scientific discipline, with 6 years of regulatory experience with US animal food additive petitions and/or human or animal GRAS conclusions.
Or MBA or post graduate/advanced degree in business or management or sciences, with 3 years of regulatory experience with US animal food additive petitions and/or human or animal GRAS conclusions.
Knowledge and understanding of fermentation products desired.
Excellent communication skills and ability to work with multi-functional teams
Experience working in a customer-focused environment
Proficiency with MS Word, Powerpoint, and Excel.
Fluency in English (verbal and written)
Expected Travel : Up to 20%
Additional: Leadership and/or Regulatory training certifications.
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.
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