Inspira Talent · 1 day ago
Associate Director Regulatory Affairs (Strategy)
New York, United States
Full-time
Hybrid
Lead/Staff, Director/ExecutiveInspira Talent is seeking an experienced Regulatory Strategy professional to support global development and lifecycle management of innovative therapeutic and combination products. This role will provide strategic regulatory leadership across development programs and partner closely with cross-functional teams to enable successful interactions with health authorities and timely approvals.
Staffing & Recruiting
Responsibilities
Develop and execute global regulatory strategies across early and late-stage development, including lifecycle planning and labeling considerations
Serve as the regulatory strategy representative on cross-functional program teams, providing guidance on risk, timelines, and regulatory pathways
Lead preparation and review of regulatory submissions, briefing packages, and agency interaction materials
Support and participate in regulatory authority meetings (e.g., FDA, EMA), ensuring alignment between development plans and regulatory expectations
Qualification
Required
Bachelor's degree required; advanced degree preferred
Significant regulatory affairs experience within biopharma, ideally including drug-device combination products or complex modalities
Demonstrated experience contributing to INDs, NDAs/BLAs, and global regulatory interactions
Strong communication skills with the ability to influence internal and external stakeholders
Preferred
advanced degree preferred
Company
Inspira Talent
Inspira is redefining success for our life science partners by offering impact-inspired staffing solutions to create unrivalled economic value.
Founded in 2024
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase