Senior Director Global Regulatory Affairs

Director/Senior Director, Global Regulatory Affairs

Cambridge, MA - United States

Summary:

We are seeking candidates to actively contribute to the development and implementation of regulatory strategy for specific projects. This Director will be the liaison and global Lead between Regulatory Affairs and other function areas including CROs, partners and consultants in the preparation, planning and organizing of regulatory documents for submission to governmental regulatory agencies. This individual will be responsible for interfacing directly with global health authorities as the primary contact for the company for assigned programs.

Responsibilities:

• Provide regulatory leadership and guidance to project teams, leadership for the development of global regulatory documents requirements.
• Thorough global regulatory understanding and responsibilities in developing strategy.
• Provide regulatory expertise and support nonclinical and clinical areas for investigational products.
• Author and review standard operating procedures (SOPs); ensure SOPs follow current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
• Identify and assess regulatory risks for assigned projects or programs
• Prepare and deliver effective presentations for external and internal audiences

Qualifications:

• M.S. degree in life sciences with a minimum of 5 years' experience in a biotech and/or pharma settings, including 4-5 years in Regulatory Affairs
• Successful track record of direct interactions with global health authorities is required
• Knowledge of global regulatory requirements required
• Recent knowledge and experience with IND preparations and submissions
• Immunology therapeutic area experience preferred
• Demonstrate strong communication skills and organizational skills
• Strong interpersonal skills and the ability to work well and effectively with a variety of staff cross-functionally
• Experience in interpretation of regulations, guidelines, policy statements, etc.