Biologics Regulatory Lead – Global Strategy & Submissions

Elanco in; Greenfield (IN); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns (mid-summer and

year-end) in the US (in addition to

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco is seeking an Associate Director, Regulatory Affairs – Biologics (Project Management) to lead regulatory strategy for biologics and vaccine programs across development and lifecycle management. You will partner with R&D, Manufacturing, Quality, and global regulatory stakeholders to ensure compliant, timely submissions.

The ideal candidate will have 5+ years in Regulatory Affairs within biologics or vaccines, strong cross-functional influence, and experience with regulatory submissions and

Qualifications

• Bachelor's degree in a scientific or technical discipline required.
• Minimum of 5 years of Regulatory Affairs experience within biologics, vaccines, biotechnology, or other regulated life sciences.
• Experience supporting regulatory strategy, submissions, health authority interactions, or agency responses.
• Knowledge of biologics development, manufacturing processes, and product lifecycle management.
• Ability to work cross-functionally and influence decisions in a matrixed environment.

Responsibilities

• Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management.
• Serve as a primary regulatory contact for health authorities (FDA, USDA/CVB, EMA, and global agencies).
• Drive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentation.
• Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management.
• Partner with R&D, Manufacturing, Quality, Technical Operations and other stakeholders to align regulatory strategy with program goals.

Skills

Regulatory Affairs

Cross-functional collaboration

Regulatory submissions

Communication

Education

Bachelor's degree in a scientific field

Job description

Elanco is seeking an Associate Director, Regulatory Affairs – Biologics (Project Management) to lead regulatory strategy for biologics and vaccine programs across development and lifecycle management. You will partner with R&D, Manufacturing, Quality, and global regulatory stakeholders to ensure compliant, timely submissions.

The ideal candidate will have 5+ years in Regulatory Affairs within biologics or vaccines, strong cross-functional influence, and experience with regulatory submissions and