Director - Regulatory Affairs

Summary:

This role provides global regulatory leadership and expertise to ensure compliance and successful submission of clinical regulatory filings. The position involves developing regulatory strategies, managing submissions, and maintaining communication with regulatory agencies and project teams.

Key Responsibilities:

• Lead global regulatory activities and strategy development for clinical regulatory filings.
• Oversee the preparation, review, and submission of regulatory documents, including INDs and FDA submissions.
• Guide project teams in interpreting and communicating regulatory requirements.
• Manage interactions with regulatory agencies and coordinate responses to inquiries.
• Monitor and assess the impact of global regulations on programs.
• Coordinate with CROs and consultants to ensure regulatory deliverables are met.
  
  

Requirements:

Necessary Experience:

• Education: BA/BS degree in biological or physical sciences preferred.
• Regulatory Experience: Minimum of 6 years in a relevant regulatory role.
  
  

Skills and Competencies:

• Strong written, oral, and interpersonal communication skills.
• Attention to detail with the ability to organize and prioritize tasks.
• Proficient in MS Office and experience with document management systems.
• Ability to work effectively in a fast-paced and dynamic environment.
  
  

Preferred Experience:

• Experience working with CROs for US eCTD IND submissions and ex-US CTAs.