Regulatory Affairs Specialist - EPA

Elanco
Indianapolis, IN
Full-time

Responsibilities :

Provide regulatory guidance for reviewing and approving promotional materials to support the food animal and pet health business of the Elanco US Affiliate.

Fulfill ALRP (Affiliate Labeling Responsible Person) duties for post-approval label changes and collaborate with regulatory innovation for pre-approval label creation.

Develop and maintain a comprehensive understanding of regulatory guidelines for EPA and NASC products.

Manage all regulatory activities related to assigned products and / or areas to ensure compliance and timely submissions.

Collaborate with cross-functional teams internally (Marketing, Legal, Technical, Labeling, etc.) and external partners to promote regulatory awareness and compliance.

What You Need to Succeed (minimum qualifications) :

Education : Bachelor’s degree or equivalent.

Required Experience : At least 3 years of relevant work experience within the sciences or related areas.

Top 2 skills : Strong collaboration skillsSelf-management skills in an environment with diverse needs and demanding timelines

What will give you a competitive edge (preferred qualifications) :

Understanding of the US regulatory landscape, preferably EPA and NASC regulatory requirements

Strong oral and written communication skills and attention to detail

Additional Information :

Travel : Up to 10% annually

Location : Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (NEW HQ COMING IN 2025 - Indianapolis, IN)

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

2 days ago
Related jobs
Elanco
Indianapolis, Indiana
Full-time

Responsibilities Provide regulatory guidance for reviewing and approving promotional materials to.. preferably EPA and NASC regulatory requirementsStrong oral and written communication skills and..

Promoted
New!
Elanco Animal Health Incorporated
Indianapolis, Indiana
Full-time

Join our team today! The Senior Payroll Specialist. United States will be responsible for the ongoing.. The Senior Payroll Specialist will also serve as an escalation point and provide timely resolution to..

Promoted
VirtualVocations
Indianapolis, Indiana
Full-time

A company is looking for a Regulatory Affairs Specialist. Key Responsibilities. Prepare documentation.. years' experience in Regulatory Affairs role Strong knowledge of IVDR and EU regulatory..

Promoted
Lumicity
IN, United States
Full-time

Lilly is looking for regulatory Chemistry Manufacturing Control (CMC) scientists to join us in.. The Senior Advisor Director in Global Regulatory Affairs. CMC will leverage CMC technical knowledge and..

Promoted
Eli Lilly and Company
Indianapolis, Indiana
Full-time

Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join us in.. The regulatory scientist in Global Regulatory Affairs. CMC Biotechnology will leverage CMC technical..

Promoted
Liberty Mutual Insurance
Indianapolis, Indiana
Full-time

Pay Philosophy The typical starting salary range for this role is determined by a number of factors including skills, experience, education, certifications and location. The full s..