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Senior Research Scientist (Regulatory Submissions Programs)

Senior Research Scientist (Regulatory Submissions Programs)

Job Location 
US-NC-Chapel Hill
Regular Full-Time

More information about this job


Rho is currently looking for a Sr. Research Scientist (Regulatory Submissions Programs) that will provide strategic and tactical leadership to projects and teams by developing viable and long-lasting solutions to cross-program, cross-functional, and organizational issues and initiatives. A particular focus of this position will be on regulatory-submissions projects for commercial clients.


  • Provides leadership, guidance, and support to a team, program, or project of large scope, as well as to the Program Management discipline within the company
  • Leads integrated product development programs consisting of clinical, preclinical, chemistry, manufacturing and controls, and regulatory components
  • Manages the strategic, regulatory authorship, biostatistical, and data submissions components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions
  • Manages scope of work, budget, and timelines for external vendors to include but not limited to contract manufacturers, package and labelers, preclinical toxicology houses, and central laboratories
  • Moderates regulatory authority meetings
  • Authors Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other complex regulatory documents
  • Ensures effective, accurate and timely communication of key issues and progress to the team and Sr. Management
  • Mentors and advises staff in areas of expertise by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
  • Proactively identifies risks and critically analyzes problems affecting the programs
  • Develops contigency plans as needed
  • Facilitates achievement of strategic goals for a program
  • Monitors ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans
  • Familiarity with GMP and nonclinical oversight activities such as manufacturing/nonclinical facilities qualification assessments, audits, and mock inspections
  • Participates in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals
  • Serves as a proposal leader for commercial and federal proposals with specific responsibility for the development and articulation of the technical strategy sections of the submission
  • Provides guidance and input to the budgets and business submissions of proposals
  • Mentors other technical leads in business development and proposal creation activities


  • PhD/PharmD or equivalent demonstration of analytical ability and 8+ years of development programs that include inter-related clinical, nonclinical, CMC, and regulatory experience
  • Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) desired
  • Experience leading multidisciplinary teams for complex regulatory submissions projects (eg, NDA submissions to FDA) is required. Familiarity with electronic-submission guidance, standards, and practices is a plus
  • Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company
  • Proven ability to establish credibility with professionals on program teams
  • Excellent regulatory intuition and project management acumen
  • Ability to understand and motivate others and build effective teams
  • Ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure
  • Excellent presentation and critical thinking skills
  • Ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
  • Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, Powerpoint, Word, etc. in addition to experience working within shared work environments

EOE. Veterans/Disabled