Senior Director Regulatory Affairs

San Diego, California

Compensation: $200,000-307,000 Bonus Equity

Company Summary:

We are partnered with an Cell Therapy focused company looking to revolutionize the way we approach cell therapy within Oncology as well as other Therapeutic areas. This organization is looking a talented Head of Regulatory affairs to spearhead a critical IND for one of their preclinical assets as well additional ones to follow. Our client's novel approach allows for their platform to operate in an "off the shelf" manner allowing for a highly efficient and scalable manufacturing process. Overtime this approach will make cell therapy much more accessible to the average patient if you want to be on the forefront of making cell therapy more accessible don't hesitate to apply!

Primary Responsibilities:

• Offer strategic guidance and supervision for clinical regulatory strategies, engagements with agencies, and document submissions.
• Collaborate with the Executive team to shape Regulatory Strategy for both internal initiatives and collaborative ventures.
• Direct the preparation, examination, and delivery of regulatory communications to authorities, encompassing pre-submission dialogues, IND/CTA filings, and responses to regulatory inquiries, ensuring accuracy, completeness, and punctuality.
• Supervise and assist in Regulatory CMC strategy matters.
• Aid development teams by interpreting and applying regulations and advisory materials, providing guidance.
• Contribute strategic insights and regulatory compliance expertise to protocols, reports, and other pertinent documents.
• Stay abreast of global regulatory guidelines, laws, and industry developments; relay crucial updates to senior leadership and project teams as appropriate; institute new procedures as needed to ensure compliance.
• Lead regulatory dialogues with agencies; create briefing materials for engagements with FDA and other regulatory bodies.
• Collaborate with cross-functional teams and support units, including permanent staff and external advisors, as required.

Qualifications:

• 8 years of Clinical Regulatory Affairs experience in drug development.
• Hands on experience with INDs, CTA, BLAs, Etc.
• Experience with regulatory submissions in the biotech