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
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