Associate Director, Regulatory Affairs – Biologics
On-site · Indianapolis, Indiana, United States
Job Summary
Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management; serve as primary regulatory contact for interactions with health authorities including FDA, USDA/CVB, EMA, and other 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; requires a Bachelor's degree and at least 5 years of Regulatory Affairs experience in biologics/vaccines or related life sciences; preference for experience in Animal Health and CMC regulatory affairs; flexible work arrangements available.
Required Qualifications
- Bachelor’s degree in a scientific or technical discipline
- Minimum of 5 years of Regulatory Affairs experience within biologics, vaccines, biotechnology, pharmaceutical, or other regulated life science environments
- Experience supporting regulatory strategy, regulatory 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
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