Director/Senior Director, CMC Regulatory Affairs
This position is based in our Corporate Headquarters in Emeryville, CA and will oversee and direct all regulatory activities pertaining to the company’s Chemistry, Manufacturing and Controls (CMC). The duties of the position will include developing and implementing CMC-related regulatory strategies for products in pre-clinical and clinical development as well as marketed products. Provide guidance to the Dynavax Quality team and ensure timely preparation of organized and scientifically valid applications. Provide expertise in translating regulatory CMC requirements into practical and workable plans, and interact with regulatory agencies.
• Partner with project leaders, department heads, and project teams to collaboratively implement the company’s CMC regulatory strategies.
• Provide strategic input and function as the regulatory lead on project teams, and will provide guidance/advice to the project leader and team on regulatory matters.
• Provide US, EU, and/or global operational input and coordination of regulatory strategies.
• Manage the assembly, review, and approval of assigned regulatory dossiers and documents (content) and the final sign-off of CMC regulatory submissions.
• Provide operational input to product lifecycle issues.
• Serve as the primary point-of-contact with the regulators for CMC topics.
• May participate in meetings with regulatory authorities, as appropriate.
• 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 Operations to ensure appropriate regulatory support of projects.
• Provide back-up support to Clinical Regulatory Affairs.
• Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
• A BA/BS with 6+ years’ CMC regulatory affairs experience, with 2 years in a management role.
• Broad to in-depth understanding of FDA and EU drug regulations and guidelines.
• Previous experience working with EU regulators, CDER and/or CBER, some CDRH experience is desired.
• Experience and knowledge in the preparation and submission of major regulatory submissions, supportive amendments, and supplements.
• Experience interfacing with relevant regulatory authorities is required.
• Collaborative and team-oriented to foster effective and positive interactions across functions, project teams, regulatory agencies, and corporate partners.
• Proven ability to manage and effectively negotiate with project team members.
• Demonstrated effective written and verbal communication skills.
• Excellent organizational skills, including the ability to prioritize and be flexible to changing priorities. Great attention to detail is a must.
• Strong interpersonal skills and able to work effectively cross-functionally.
• Experience in project team management.
• Fluent knowledge of all stages of pharmaceutical drug development with emphasis in operations compliance and documentation.
• Clinical and commercial labeling and/or supply chain regulatory experience desired.
Dynavax is an Equal Opportunity Employer