Associate Director – Regulatory Affairs – Genetic Medicine & Thrombosis
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Berkeley Heights, NJ, USA, Tarrytown, NY, USA |
| Salary | $173500 – $283100 |
| Type | Full-Time |
| Degrees | PharmD, PhD, MD |
| Experience Level | Senior |
Requirements
- MD, Ph.D. or Pharm D. degree
- Minimum of 7 years of pharmaceutical industry experience
- At least 6 years of regulatory experience
- Excellent written and verbal communication skills
Responsibilities
- Provide leadership on global regulatory activities for assigned products
- Focus on Clinical Regulatory filings and provide regulatory leadership on project teams
- Support some clinical study activities
- Lead and/or supervise IND/CTA and BLA submissions activities
- 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
- Utilize regulatory expertise to interpret, plan, and communicate requirements
- Ensure 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
- Plan, prioritize, supervise and/or conduct activities in collaboration with leads from other areas
- Assure compliance with regulations and project team timelines
- Provide interpersonal support and lead personnel
Preferred Qualifications
- Good understanding of US FDA and international pharmaceutical guidance
- Experience interacting with CROs in the management of ex-US/ex-EU CTAs preferred
- High attention to detail
- Ability to coordinate and prioritize assigned projects according to company goals
- Strong interpersonal skills both written and verbally