About this role
Role Overview
- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development
- Assist in coordination and preparation for Agency meetings and associated briefing document preparation
- Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries
- Provide periodic status updates regarding conditions/commitments
- Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
Requirements
- MD, PhD or PharmD degree
- 2+ years of regulatory experience
- Good understanding of US FDA and international pharmaceutical guidance
- Knowledge of drug development process and industry standard practices
- Interaction with CROs in the management of ex-US/ex-EU CTAs preferred
- Strong interpersonal skills both written and verbally
- Ability to coordinate and prioritize assigned projects according to company goals
Benefits
- Health and wellness programs (including medical, dental, vision, life, and disability insurance)
- Fitness centers
- 401(k) company match
- Family support benefits
- Equity awards
- Annual bonuses
- Paid time off
- Paid leaves (e.g., military and parental leave) for eligible employees at all levels!