Senior Director, Regulatory Affairs - Remote

Regulatory Affairs United States


Position at Regulatory Professionals

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.

We’re looking for a talented and innovative Sr. Director, Regulatory Affairs, to join our team!

As the Sr. Director, Regulatory Affairs, you’ll have the opportunity to develop, implement, and lead both regional and international strategy for assigned projects with various cross-functional teams and senior level client collaborations. You’ll oversee the execution of regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development and post approval and address the analysis and evaluation of regulatory procedures and changes to ensure attainment of corporate goals. You will provide guidance for, and actively contribute to, the development of documents for Investigational New Drug applications (INDs)/Investigational Medicinal Product Dossiers (IMPDs)/Clinical Trial Applications (CTAs), and New Drug Applications (NDAs)/Biologics License Applications (BLAs), ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, complete, and approvable on the first review cycle. In this role, you will also manage and mentor others within the Regulatory Affairs skill group.

This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities. Accommodations for new hires who have qualifying medical conditions or sincerely held religious beliefs that conflict with this requirement will be considered on an individual basis.

What you’ll be doing:

  • Develop and execute international and regional strategies and contingencies for assigned projects
  • Lead both international and regional regulatory teams on assigned projects
  • Develop and implement creative approaches to ensure regulatory success
  • Provide efficient and effective Regulatory representation across the organization and act as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies
  • May serve as the interim Head of Regulatory Affairs for assigned clients/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, breakthrough designations, and NDAs/BLAs
  • Direct cross-functional teams to define contributions to submissions
  • Think ‘analytically and strategically’ and convey complex concepts in an understandable manner
  • Interface with international affiliates on regional regulatory strategy and implementation plans
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
  • Conduct business development efforts
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures
  • Effectively communicate comments/recommendations and proactively engage program teams to establish solutions to issues
  • Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs skill group
  • Review and approve timesheets and expense reports and guide the performance of assigned staff

You’ll need this to be considered:

  • Bachelor’s degree (PhD preferred) in science or health related field along with 15+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry including 9-11 years progressive regulatory affairs experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company and 7 years supervisory/management experience
  • Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies along with leadership experience in the establishment of INDs and approvals of NDAs and BLAs; expert in the drug development process with experience in multiple phases (early and late stage, post-approval) in various therapeutic areas- Strong preference for Oncology expertise.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
  • Results driven and team-orientated, with the ability to influence outcomes as necessary
  • Able to develop and implement creative approaches to ensure regulatory success
  • Able to innovate, analyze, and solve problems with minimal supervision
  • Exceptionally keen attention to detail
  • Demonstrated ability to manage a staff of up to 5 associates to achieve company and client goals