Senior Manager, Regulatory Affairs
This position will lead the regulatory advertising and promotion activities pertaining to the company’s marketed product, HEPLISAV-B®, and will lead specific, and support all, regulatory activities across the company’s overall regulatory strategy, clinical regulatory and regulatory-CMC, spanning preclinical and Phase 1 product development to marketed product activities.
The duties of the position will include developing and implementing advertising and promotion regulatory strategies for the product. Provide guidance to the Dynavax Commercial and Medical teams and ensure timely preparation external materials.
In the leadership and support roles for the company’s overall regulatory strategy, clinical regulatory and regulatory-CMC, this position is responsible for generating organized and scientifically valid submissions to regulators, building relationships with regulator contacts and developing internal regulatory strategies based on regulations, guidance, precedents and regulatory landscape.
- Partner with project leaders, department heads, and project teams to collaboratively develop and implement the company’s advertising and promotion strategies while maintaining regulatory compliance.
- 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) of regulatory submissions.
- Provide operational input to product lifecycle issues.
- Serve as the primary point-of-contact with the regulators.
- Lead and/or 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.
- 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 5+ years’ regulatory advertising and promotion experience or PharmD with 3+ years’ regulatory advertising and promotion experience, and 2+ years of other regulatory strategy experience.
- Broad to in-depth understanding of FDA drug regulations and guidelines.
- Previous experience working with CDER and/or CBER experience.
- Previous experience supporting Regulatory CMC is desired.
- Experience and knowledge in the preparation and submission of major regulatory submissions, supportive amendments, and supplements.
- 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.
Dynavax is an Equal Opportunity Employer