Independent Contractor – Clinical Trials Quality & Compliance Manager
Cardiovascular Associates of America - CVAUSA
Google Cloud Platform
Senior Director, Regulatory Affairs
Dynavax Technologies
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $270,000 - $297,000 per year
Job Level
Senior
About the role
- Provide regulatory oversight for multiple projects focused on non-clinical and clinical aspects of drug development and associated regulations.
- Collaborate within Regulatory as well as with functional counterparts to ensure a global regulatory strategy is created and executed for all assigned projects.
- Align with senior leadership on each proposed project regulatory strategy.
- Serve as the internal Regulatory leader for other region activities (e.g., EU/UK filings, global partnerships, ex-US clinical trial applications).
- Support all regulatory activities across the company’s overall regulatory strategy, spanning preclinical to Phase 4 product development, including marketed product activities.
- Develop and implement regulatory strategies for assigned products based on regulations, guidance, precedents, and regulatory landscape.
- Develop relationships with FDA contacts and lead FDA engagement strategies and execution.
- Guide submissions to the INDs and BLA, tracking commitments and submission requirements.
- Partner with cross-functional subject matter experts to develop a CCDS / country label prior to Phase 3 to support the path to registration.
- Drive development of (s)BLA strategy for registration of assigned programs.
- Coordinate submission requirements and regulatory engagement strategies in collaboration with external resources.
Requirements
- 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.
- Previous experience leading cross-functional teams on regulatory strategy development and execution.
- 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.
- Excellent organizational skills, including the ability to prioritize and respond to changing priorities.
- Strong interpersonal skills and ability to work effectively cross-functionally.
- 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.
Benefits
- Health insurance
- 401(k) company match
- Paid time off benefits
- 17 paid holidays in 2025
- Participation in our Company’s discretionary annual bonus program
- Stock equity awards
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory oversightregulatory strategy developmentIND submissionsBLA submissionsregulatory engagement strategiesclinical trial applicationspharmaceutical drug developmentregulatory submissionsoperations compliancelabeling
Soft skills
organizational skillsinterpersonal skillsanalytical problem solvingcommunication skillscross-functional collaborationleadershipdecision makingprioritizationnegotiationteam management
Certifications
Bachelor's degreeadvanced scientific related degree
