Position: Executive Director, Regulatory Affairs - Cardiovascular Job #2085
Location: NJ or NY
Compensation: Based Upon Experience
The Executive Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for the client’s clinical asset candidates.
• Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
• Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Lead the preparation of major clinical submissions required for regulatory approval.
• Work with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
• Responsible for quality and timeliness of IND/CTA and BLA/MAA submissions. Interacts with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
• Effectively plan, organize, supervise and/or conduct regulatory activities in close collaboration with leads from other functional areas. Assure compliance with regulations and with project team timelines and milestones.
• Provide organizational support and manage personnel.
Education: Ph.D. or Pharm D. Required