Director, Regulatory Affairs

Regulatory Professionals is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world. With a presence in the US, EU, Canada and Japan we are growing and looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture.

Responsibilities

  • Develop and implement regulatory strategy for assigned projects including small molecules, biologics, cell and gene therapies
  • Lead global and/or regional regulatory team on assigned projects.
  • Develop and execute global and/or US regulatory strategy and contingencies for assigned projects.
  • Serve as the primary interface for FDA on assigned projects.
  • Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with cross-functional teams to define contributions to submissions. Lead regulatory for submission teams for projects assigned.
  • Prepare clients for FDA and other regulatory health agency meetings, as required.
  • Represent Regulatory Affairs on various cross-functional teams, including Project Teams.
  • Represent regulatory in senior management discussions and present issues accordingly.
  • Interface with international affiliates on regional regulatory strategy and implementation plans.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance.
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
  • Conduct Business Development efforts, if assigned.

Qualifications - Skills/Knowledge Required:

  • Degree in scientific discipline; advanced scientific degree (PhD) preferred.
  • Experience in multiple phases of development in various therapeutic areas.¬†Experience in cell/gene therapy and/or oncology is highly desired
  • A minimum of 10 years pharmaceutical industry with a minimum of 7 years in regulatory affairs. Global experience desirable.
  • Thorough knowledge of the drug development process, with a focus on IND and NDA processes.
  • Demonstrated experience in preparing new INDs/CTAs and/or NDAs/BLAs/MAAs submissions.
  • Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
  • Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Demonstrated ability to manage staff to achieve company and client goals.
  • Must be able to innovate, analyze and solve problems with minimal supervision and exceptionally keen skills for attention to detail.

RPI is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

RPI complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for RPI in the U.S.

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