Eli Lilly and Company
This role provides global strategic regulatory oversight and is assigned regulatory accountability on vaccine/biopharmaceutical research and development projects.
This is accomplished through expert knowledge and understanding of regulations, guidelines, regulatory precedence and the evolving regulatory framework to expedite the research/development and delivery of safe and effective products for animals.
To accomplish this purpose, it is necessary for the Consultant to develop, maintain and extend relationships across Elanco components, regulatory agencies, partner companies, industry groups, and academia.
Functions, Duties, Task:
Provide leadership of the development and execution of regulatory strategies supporting licensure of new products and claim extensions.
Anticipate and resolve key regulatory problems of global vaccine developments.
Coordinate and/or conduct the preparation of new biological applications, submissions and responses to questions posed by regulatory agencies.
Author and/or review of appropriate policies, SOPs, and guidance documents as needed.
Maintain a positive business relationship with regulatory authorities.
Align with global, regional and affiliate Regulatory staff to make sure local regulations are met.
Work effectively and flexible within all related Elanco disciplines and external collaborators to achieve overall Elanco RA deliverables.
Deliver scientifically sound high quality and approvable product submissions.
Provide and accept challenge to deliver innovative scientific and regulatory solutions and create innovative culture.
Supervise Elanco employees or Contractors and perform appropriate MyPM activities as applicable.
Manage project timeline and budget deliverables to facilitate delivery and maintenance of the Elanco pipeline
10 years experience in research & development and regulatory functions with experience in USDA licensure of biologicals
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
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.
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity and respect for people.