Associate Director, Regulatory Affairs
$190,000–$200,000 year
Remote · United States or New York City, New York, United States
Job Summary
Associate Director, Regulatory Affairs needed to lead regulatory strategies and submissions for novel biologics/drugs in early phase development, coordinating with FDA/global authorities, preparing INDs and amendments, and guiding cross-functional teams to ensure timely, high-quality regulatory filings. Role involves regulatory lead responsibilities from nonclinical to clinical and marketing applications, preparation and coordination of complex submissions, regulatory impact assessments, adherence to GxP/SOPs, and supporting broad business initiatives. Remote or office-based in the US with travel up to 20%. Requires strong leadership, project management, scientific background in biology/immunology, and experience with INDs, clinical trials, and marketing applications.
Required Qualifications
- Bachelor’s degree in biological or pharmaceutical sciences
- Seven (7) years of experience in pharmaceutical or health care industry experience or equivalent
- Five (5) years in early and late stage regulatory drug development
- Knowledge of FDA and EU regulations and ICH requirements
- Experience directly writing submission documents that support IND applications, clinical trials, and marketing applications
- Experience developing and implementing regulatory strategies
- Ability to travel up to 20%
- Dedicated team player who is able to withstand the high demands of a fast-paced environment
- Strong planning and organizational skills and attention to detail with accuracy and quality
- Excellent written and verbal communication skills
- Able to work independently with minimal supervision and collaboratively with team members
- Able to effectively interact with internal and external parties to drive projects through to completion to tight timelines
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