Hybrid Senior Director, Regulatory Affairs

Posted last month

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About the role

  • 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

Job title

Senior Director, Regulatory Affairs

Job type

Experience level

Senior

Salary

$215,000 - $275,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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