Regulatory Affairs Consultant – R&D

Elanco

Regulatory Affairs Consultant ensuring compliance and timely submissions for FDA-CVM pharmaceutical products at Elanco. Collaborating with teams for regulatory guidance and project leadership.

Posted 5/22/2026full-timeIndianapolis • 🇺🇸 United StatesMid-LevelSenior💰 $118,800 - $150,000 per yearWebsite

About the role

Key responsibilities & impact

Represent the Regulatory US Affiliate to ensure regulatory compliance and timely submissions for post-approval regulatory activities related to assigned pharmaceutical (FDA-CVM) products.
Maintain a broad overview of all post-approval activities related to assigned products and/or areas of responsibility.
Provide regulatory guidance in the development and approval of promotional materials for the Elanco US Affiliate.
Support post-approval label changes, CMC updates, periodic reports and other post-approval submissions to FDA-CVM.
Lead project teams to comply with non-standard post-approval requests and authority mandates.
Collaborate with other functional areas (Global CMC, Marketing, Legal, Technical, Labeling, Supply Chain, Quality, etc.) and external partners to promote regulatory awareness of and compliance with applicable regulations.
Represent Elanco in direct communications with FDA-CVM and maintain positive business collaboration.

Requirements

What you’ll need

Master’s degree or equivalent with at least 5 years relevant work experience within the sciences or related areas.
Solid understanding of US FDA-CVM regulatory post-approval requirements
Strong ability to interpret and leverage scientific data for promotional purposes while maintaining compliance with regulations.

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

regulatory compliancepost-approval submissionspromotional materials developmentlabel changesCMC updatesperiodic reportsscientific data interpretation

Soft Skills

collaborationleadershipcommunication

Certifications

Master’s degree