North AmericaFull TimeHealthcare
Remotely
gcpregulatory affairsclinical trialsregulatory submissionsregulatory strategyctaind
Job Description
📋 Description
- Provides regulatory development advice for clinical development life cycle
- Coordinates and reviews regulatory submissions to Authorities/Ethics Committees (CTA/IND, annual
- Maintains current regulatory knowledge and supports project teams and regulatory function
- Serves as Global Regulatory Affairs representative at project team meetings
- Oversees regulatory targets, plans, and intelligence tools; leads regional/global projects when
- Maintains project plans and trackers; updates Regulatory Leadership
🎯 Requirements
- Bachelors degree required; plus experience in scientific/healthcare field preferred
- 5+ years or more regulatory affairs experience
- Strong knowledge of EU/US regulatory activities, including INDs/CTAs, submissions, scientific
- Understanding of clinical and pre-clinical study results; ability to interpret data for regulatory
- Knowledge of ICH GCP guidelines; familiarity with regulatory milestones and milestones planning
- Fluent in English; excellent written and verbal communication; strong interpersonal skills
🎁 Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
