Hybrid Senior Director, Regulatory Affairs

at Arcus Biosciences

• Job title: Senior Director, Regulatory Affairs
• Job type: Full Time
• Experience level: Senior
• Salary: $215,000 - $275,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Hayward, United States

About the role

• Senior Director of Regulatory Affairs at Arcus Biosciences leading regulatory strategies for clinical trial applications and marketing approvals. Managing a regulatory team and ensuring compliance with US and international regulations.

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
• 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

Requirements

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

Benefits

• Opportunity to participate in stock programs
• Performance-based bonus
• Comprehensive benefits package