Senior Director, Regulatory Affairs (Office or Remote)

Role Summary

The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally. Acts as a resource to the broader regulatory function, including mentorship of less experienced staff. Note: Regulatory Group works Pacific Time Zone hours. This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based.

Responsibilities

• Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success
• Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets
• Represents the regulatory function on cross-functional development teams
• Plans, prepares, and reviews submissions to regulatory authorities including FDA, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA)/Biologic Licensure Application (BLA), and Marketing Authorization Application (MAA).
• Works with regulatory submissions coordinator to develop submission timelines and work with cross-functional teams to planned objectives
• Serves as the primary point of contact with FDA and other health authorities as applicable
• Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of interaction
• Manages all maintenance plans for regulatory investigative and marketing applications for assigned projects
• Manage and provide guidance/training for regulatory staff members, including regular feedback and coaching for professional development
• Develop relationships with external partners
• Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs
• Provides regulatory guidance and/or training to external departments
• Prepares and revises internal procedures for continuous improvement
• Manages activities performed by regulatory

Qualifications

• A minimum of 8+ years in regulatory affairs with 12+ years in the biotech/pharma industry relevant to the respective regulatory function with experience in a leadership role.
• Experience in oncology drug development a must.
• Thorough knowledge of US and international regulations as they apply to pharmaceutical and biologic drug development
• Previous experience managing development of INDs and other global clinical trial applications
• Experience leading regulatory agency interactions, meetings
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective
• Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills
• Demonstrated problem solving abilities and conflict resolution skills
• Proficiency in MS Office applications and internet researching
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals

Education

• Bachelor’s degree in a life science required; PhD, PharmD or Master's degree preferred