Responsibilities :
Design and develop creative global regulatory strategy and technical regulatory documents based on interpretation of both regulatory and scientific information
Possess knowledge of and compliance with relevant laws and regulations, and global policies and procedures
Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners / customers and maintaining positive relationships with those parties.
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 delivery of compliant commercial labels during the pre-launch phase across major geographies (EU / US), ensuring timely market access and regulatory compliance.
What You Need to Succeed (minimum qualifications) :
Education : Minimum master’s degree; DVM or PhD highly desired
Required Experience : A minimum of 5 years of experience in animal health industry (companion animal health preferred)
Top Skills Needed : Regulatory affairs experience, and understanding of the animal health industry and the animal drug development process
What will give you a competitive edge (preferred qualifications) :
More years of experience in the industry
DVM or PhD
Strategic thinking and ability to design and develop innovative global regulatory strategies
Effective collaboration and skills in collaborating with cross-functional teams
Additional Information :
Travel : Expected travel is up to 15%
Location : Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification.
At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply.
You may be the right candidate for this role or other roles!
Elanco Benefits and Perks :
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include :
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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