Associate Director, Regulatory Affairs Strategy

The Role:

• This highly dynamic team is seeking a motivated and entrepreneurial Associate Director to play a key role on the cross-functional R&D team.
• You will support global regulatory strategies that expedite development and maximize probability of success.

Key Responsibilities:

• Support and contribute to regulatory strategies and help mitigate risks.
• Plan, prepare, and coordinate regulatory documents for submissions to global health authorities.
• Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.

Requirements:

• 8+ years of biopharmaceutical experience with at least 4 years in Regulatory Affairs.
• Experience in biologics or small molecule drug development and global regulatory environment.
• Strong problem-solving skills and ability to adapt to changing priorities.

Work Environment:

• Remote-based, dynamic, fast-paced, and entrepreneurial environment.
• Domestic or international travel required (10-20%).