Director, Regulatory Affairs

Director, Regulatory Affairs

Location: San Mateo, CA

Position Overview:

The Director of Regulatory Affairs will lead global regulatory activities with a focus on clinical filings. This role involves guiding regulatory strategy, managing submissions, supporting clinical trial applications, and ensuring compliance with regulatory requirements.

Key Responsibilities:

• Lead global regulatory strategy and planning, focusing on clinical regulatory filings.
• Oversee IND submissions, ensuring compliance with regulatory standards.
• Manage the preparation, review, and tracking of regulatory documents.
• Provide guidance on regulatory requirements to project teams and governance bodies.
• Coordinate with vendors to ensure timely communication and deliverables.
• Manage interactions with regulatory agencies and respond to inquiries.
• Ensure proper review, finalization, and archiving of regulatory submissions.

Required Qualifications:

• BA/BS degree in biological or physical sciences preferred.
• At least 6 years of regulatory science experience, including experience with US eCTD IND submissions and ex-US CTAs.
• Proficiency in written, oral, and interpersonal communication.
• Strong attention to detail, organizational skills, and ability to prioritize tasks.
• Experience with MS Office and electronic document management systems.
• Ability to collaborate effectively with colleagues across departments.
• Ability to thrive in a fast-paced, entrepreneurial environment.

Preferred Experience:

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

Disclaimer:

This job description outlines the general nature and level of work expected for this role. It is not an exhaustive list of all responsibilities, duties, and skills required.