Regulatory Affairs Promotional Review Consultant
Elanco
16 days ago
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Regulatory Affairs Promotional Review Consultant
Your Responsibilities:
- Maintain a broad overview of all post-approval activities related to assigned products/areas of responsibility.
- Provide regulatory guidance for the development and approval of promotional materials for the US Affiliate.
- Support post-approval label changes, CMC updates, periodic reports, and other FDA-CVM post-approval submissions (including compilation, submission, and archival).
- Lead project teams to comply with non-standard post-approval requests and authority mandates.
- Collaborate with internal functional areas and external partners to ensure regulatory awareness and compliance.
- Represent Elanco in communications with FDA-CVM (written and by leading meetings as required).
- Maintain positive business collaboration and influence with regulatory affiliates, Reg Innovation, FDA-CVM, and industry groups.
- Perform other related duties as directed by management.
What You Need to Succeed (Minimum Qualifications):
- Master’s degree (or equivalent) with at least 5 years relevant science-related experience.
- Solid understanding of US FDA-CVM regulatory post-approval requirements.
- Ability to interpret and leverage scientific data for promotional purposes while maintaining regulatory compliance.
What will give you a competitive edge (Preferred Qualifications):
- Experience reviewing promotional/technical materials in the FDA/EPA space.
- Strong self-management in environments with diverse needs and urgent timelines.
- Ability to collaborate across organizations to develop compliant solutions.
- Strong oral/written communication skills and attention to detail.
Additional Information:
- Travel: domestic and international up to 5%.
- Location: Indianapolis, IN.
Benefits and Perks (highlights):
- Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401(k) matching.
Your Responsibilities:
- Maintain a broad overview of all post-approval activities related to assigned products/areas of responsibility.
- Provide regulatory guidance for the development and approval of promotional materials for the US Affiliate.
- Support post-approval label changes, CMC updates, periodic reports, and other FDA-CVM post-approval submissions (including compilation, submission, and archival).
- Lead project teams to comply with non-standard post-approval requests and authority mandates.
- Collaborate with internal functional areas and external partners to ensure regulatory awareness and compliance.
- Represent Elanco in communications with FDA-CVM (written and by leading meetings as required).
- Maintain positive business collaboration and influence with regulatory affiliates, Reg Innovation, FDA-CVM, and industry groups.
- Perform other related duties as directed by management.
What You Need to Succeed (Minimum Qualifications):
- Master’s degree (or equivalent) with at least 5 years relevant science-related experience.
- Solid understanding of US FDA-CVM regulatory post-approval requirements.
- Ability to interpret and leverage scientific data for promotional purposes while maintaining regulatory compliance.
What will give you a competitive edge (Preferred Qualifications):
- Experience reviewing promotional/technical materials in the FDA/EPA space.
- Strong self-management in environments with diverse needs and urgent timelines.
- Ability to collaborate across organizations to develop compliant solutions.
- Strong oral/written communication skills and attention to detail.
Additional Information:
- Travel: domestic and international up to 5%.
- Location: Indianapolis, IN.
Benefits and Perks (highlights):
- Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401(k) matching.