Senior Manager/Associate Director, Regulatory Affairs - Berkeley, CA | Biospace
Get Our FREE Industry eNewsletter

Senior Manager/Associate Director, Regulatory Affairs

Dynavax Technologies

Apply
Location:
Berkeley, CA
Posted Date:
7/24/2017
Position Type:
Full time
Job Code:
17-031N
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Regulatory Affairs,

Job Description


Manage and lead regulatory activities for assigned programs to ensure alignment and compliance with local, federal, and other regional registration requirements, as well as with company policies.

Responsibilities:
•   Partner with project leaders, department heads, and project teams to collaboratively implement the company’s regulatory strategies.
•   The associate director level incumbent will 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 regulatory submissions.
•   Provide input to target labeling content (MDS, SmPC, US package insert, container packaging, etc).
•   Provide operational input to product lifecycle issues.
•   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.
•   Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
•   Other duties as assigned.

Requirements


•   A BA/BS with 6+ years’ clinical regulatory affairs experience, with 2 years in a management role. The associate director level will have 8+ years’ experience and 3+ years’ management experience with lead clinical and/or CMC regulatory responsibilities.
•   Broad to in-depth understanding of FDA drug regulations and guidelines, from either clinical development or CMC.  
•   Previous experience working with CDER and/or CBER, some APLB/DDMAC is required.
•   Experience and knowledge in the preparation and submission of major regulatory submissions, supportive amendments, and supplements.
•   Experience interfacing with relevant regulatory authorities highly preferred.
•   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 clinical development and operations compliance and documentation.