Director of Regulatory Affairs (San Francisco, CA)

Director of Regulatory Affairs (San Francisco, CA)

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 :

Department : Direct Clients

This is a full time position

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