Regulatory Affairs Consultant- R&D

Elanco is seeking a Regulatory Affairs Consultant- R&D to ensure regulatory compliance and timely submissions for post-approval regulatory activities related to assigned pharmaceutical products. The role will provide regulatory guidance, support label changes, and collaborate with internal and external partners to promote regulatory awareness and compliance.

Requirements

• 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 and external partners to promote regulatory awareness of and compliance with applicable regulations and internal policies and procedures.

Benefits

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching