Director – Global Regulatory Lead – Genetic Medicine
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Westchester County, NY, USA, Berkeley Heights, NJ, USA, Tarrytown, NY, USA |
| Salary | $202000 – $336600 |
| Type | Full-Time |
| Degrees | PharmD, PhD, MD |
| Experience Level | Expert or higher |
Requirements
- MD, Ph.D. or Pharm D. degree
- Minimum of 10 years of pharmaceutical industry experience
- At least 7 years of regulatory experience
- Excellent written and verbal communication skills
- Ability to thrive in a fast-paced, entrepreneurial environment
Responsibilities
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines
- Lead the development of regulatory strategic plans
- Own the preparation of major clinical submissions required for regulatory approval
- Work with project teams to resolve complex project issues
- Responsible for quality and timeliness of IND/CTA and BLA submissions
- Interact with other functions and partners in the preparation, review, and completion of documents for regulatory submissions
- Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas
- Assure compliance with regulations and with project team timelines
- Provide interpersonal support and lead personnel
Preferred Qualifications
- Good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
- Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
- High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
- Strong interpersonal skills both written and verbally