Title: Director-Regulatory Affairs III
Location: Rahway, NJ
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
- Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
- Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
- Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
- Represents with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare teams for meetings with FDA at any phase of drug development.
- Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
- Coordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
- Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from the company to external agencies and investigators.
- Represent GRA within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and LEAD.
- Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
- Participate in regulatory due diligence activities for licensing candidate review.
- B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs
- M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs
- PhD with minimum of 7 years relevant regulatory experience
- M.D. with minimum of 5 years regulatory experience
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead
- Led meetings with FDA, EMA, or other Health Authorities
- Led regulatory filings for New Drug Applications or Efficacy Supplemental Applications
- Oncology experience
- Immunology and biologics experience
- Substantial experience in regulatory affairs in one major country/region (eg. USA, EU).
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Clinical Study Reports