Senior Director, Regulatory Affairs

Dynavax TechnologiesEmeryville, CA, United States

17 hours ago

Job type

Full-time

Job description

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 company's 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

Bachelor's degree with advanced scientific related degree preferred.

A minimum of 10+ years of regulatory experience (or advanced degree with 5+ years' regulatory experience) and at least 2 years in a management role. Less experience may be considered depending upon previous roles and responsibilities.

Previous experience leading cross-functional teams on regulatory strategy development and execution. Collaborative and team-oriented with ability to lead, manage and effectively negotiate with project team members and senior management.

Previous experience working with global regulators; demonstrated experience of successful interactions and negotiations with EMA, MHRA, CDER and / or CBER, is desired.

Broad, in-depth understanding of FDA drug regulations and guidelines with prior experience working with CDER and / or CBER.

Collaborative and team-oriented approach to foster effective and positive interactions across functions, project teams, regulatory agencies, and corporate partners.

Strong interpersonal skills and ability to work effectively cross-functionally.

Excellent organizational skills, including the ability to prioritize and respond to changing priorities.

Creative, analytical problem solver, who acts decisively, yet communicates potential consequences so that informed business decisions can be made.

Fluent knowledge of all stages of pharmaceutical drug development with emphasis in operations compliance and documentation.

Preferred experience in managing multiple filings or managing multiple programs in closely related development area.

Experience and knowledge in the preparation and submission of major regulatory submissions, supportive amendments, and supplements.

Clinical and commercial labeling and / or supply chain regulatory experience desired.

Demonstrated effective written and verbal communication skills.

Experience in managing direct reports desired.

Ability to sit for prolonged periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and / or fingers.

Occasional travel required, as needed.

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 Company's 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.

#LI-REMOTE

Create a job alert for this search

Director Regulatory • Emeryville, CA, United States