Sr. Director, Regulatory Affairs-Oncology

Location
South San Francisco, CA
Posted
Nov 12, 2018
Discipline
Science/R&D, Oncology
Required Education
Bachelors Degree
Position Type
Full time

Summary:
This is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. This position manages the day-to-day regulatory activities of assigned projects for compounds under development. These activities include acting as the regulatory representative on core teams, developing and planning regulatory submission strategy, coordinating/overseeing the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities. The Sr. Director, Regulatory Affairs, interacts with regulatory agencies and ensures the timely preparation of scientifically valid submissions. 

Specific responsibilities include, but are not limited to: 

  • Lead the development of regulatory strategy for multiple and/or complex small molecule projects in development (from FIH to commercial) 
  • Oversee and work with approved clinical research organizations (Global Regulatory Program Leads and Regional Representatives) or other partnering organizations and coordinating international submissions to meet regulatory requirements 
  • Work with internal/external team members to ensure unified regulatory input into cross-functional development teams, clinical programs, and early to late stage development strategy 
  • Participating in meetings as the representative of Regulatory Affairs to address complex issues, providing innovative regulatory solutions and guidance to cross-functional and core project development teams and well as to meet corporate goals 
  • Serving as the primary interface for FDA, EMA and other regulatory agencies on assigned projects 
  • Ensure compliance of regulatory strategies and submissions with current regulations and guidance 
  • Leading the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, NDAs and MAAs, etc 
  • Assess project plans and timelines and assign and manages internal/external team members and consultants to ensure all projects are appropriately prioritized and key goals are met on time 
  • Maintaining knowledge of global competitive landscape, regulatory environment, regulations and guidelines 
  • Develop and implement standard operating procedures for the continuous development and maintenance of Regulatory Affairs Department 
  • Supervising others in Regulatory Affairs i.e., consultants 
  • Other duties as assigned 
  • Adherence to the company's Code of Business Conduct & Ethics 

Qualifications include: 

  • Bachelor’s or advanced degree (Ph.D./MS) in scientific/life-sciences or related field with at least 12 years of pharmaceutical industry experience and 8+ years of direct regulatory affairs experience 
  • Capable of strategic thinking and proposing innovative solutions to regulatory challenges with minimal supervision and have exceptional attention to detail 
  • Experience in multiple phases of development in various therapeutic areas. Oncology experience required 
  • Able to provide regulatory leadership on cross-functional teams 
  • Advanced knowledge of the drug development process, with focus on IND/CTA and NDA/MAA processes 
  • Experience with small molecule products is highly desired 
  • Demonstrated ability to interface with relevant global regulatory authorities 
  • Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy 
  • Demonstrated eCTD experience preparing new IND/CTA and/or NDA/MAA submissions and supportive material 
  • Results driven and team-oriented with the ability to influence outcomes 
  • Excellent organizational, written and verbal communications, project and time management skills needed to impact and influence the decisions of a team and drive multiple ongoing projects simultaneously 
  • Ability to communicate with all levels within the company and act as liaison / representative both internally and externally 
  • Communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents 
  • Good computer skills and strong working knowledge of the MS Office suite (Word, Excel, PowerPoint) 
  • Supervisory experience required