Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

The Senior Director, Regulatory Affairs position provides regulatory oversight for multiple projects focused on non-clinical and clinical aspects of drug development and associated regulations. This leadership role collaborates within Regulatory as well as with functional counterparts to ensure a global regulatory strategy is created and executed for all assigned projects. The role will also align with senior leadership on each proposed project regulatory strategy. In addition, this role will also serve as the internal Regulatory leader for other region activities (e.g., EU / UK filings, global partnerships, ex-US clinical trial applications), including collaborating with external counterparts as needed. This position will support all regulatory activities across the companys overall regulatory strategy, spanning preclinical to Phase 4 product development, including marketed product activities.

This position is also responsible for developing and implementing regulatory strategies for assigned products based on regulations, guidance, precedents and regulatory landscape, include but not limited to, developing relationships with the FDA contacts, leading FDA engagement strategies and execution, leading submissions to the INDs and BLA, tracking commitments and submission requirements. This role will partner with cross-functional subject matter experts to develop a CCDS / country label prior to Phase 3 to support the path to registration and partner with functional leads to drive development of (s)BLA strategy for registration of assigned programs. Duties related to ex-US activities include coordination of submission requirements and regulatory engagement strategies in collaboration with external resources. Additional responsibilities related to strategic initiatives, due diligence, and policy development will be assigned on an as needed basis.

Responsibilities

• Oversee regulatory responsibilities for multiple projects and provide strategic input on regulatory matters to the project leader and team. Functions as the global regulatory lead on project teams.
• Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to project team and / or higher governance bodies in these areas.
• Accountable for developing and integrating US, EU, and / or global regulatory strategies and providing operational input, where needed. May serve as the primary point of contact with regulators.
• Present, discuss and align with Senior Leaders on the proposed regulatory strategy.
• Lead and / or participate in meetings with regulatory authorities, as appropriate.
• Manage the assembly, review, and approval of assigned regulatory dossiers and documents (content) of regulatory submissions.
• Partner with cross-functional representatives to develop the CCDS and country-specific label to support late-stage development and registration.
• May supervise one or more direct reports and their programs. Manage, train and provide oversight for staff day-to-day activities.
• Manage the regulatory work of CROs and consultants.
• May provide regulatory due-diligence support for partnering and licensing activities.
• Work closely with and coordinate project-related activities with Regulatory and functional counterparts to ensure appropriate regulatory support of projects.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
• Other duties, as assigned.

Qualifications

$270,000 - $297,000 a year

The estimated salary range for this position is $270,000 to $297,000. Final pay determinations may depend on various factors, including, but not limited to experience level, education, geographical location, knowledge, skills, and abilities. The total compensation package for this position also includes other compensation elements such as stock equity awards and participation in our Companys discretionary annual bonus program. Dynavax also offers a full range of health and welfare insurance benefits, 401(k) company match, and paid time off benefits, including 17 paid holidays in 2025.