Manager/Sr Manager, Regulatory Affairs - Remote

Regulatory Affairs United States


Description

Position at Regulatory Professionals

Bring your Passion!

Regulatory Professionals, a division of Premier Research, 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. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.

You’ll be doing:

The Manager, Regulatory Affairs provides regulatory support for clinical trial applications, which includes investigational new drug applications and clinical trial applications, marketing applications, and ongoing trials and post approval activities. In addition, the role is responsible for working with cross-functional teams to manage the preparation, review and assembly of regulatory submissions to U.S. and international health agencies. The Manager contributes to regulatory strategy, identifying risks and opportunities, while leading both simple and complex regulatory applications and managing procedures through approval. This position aligns client objectives with clearly defined scope of work and deliverables, may manage internal project resources, delivers projects/programs on time & on budget, and ensures overall client satisfaction. This position also supports the client project team that authors and reviews all materials required in submissions and interacts with regulatory agencies. The Manager may supervise or manage others within the Regulatory Affairs skill group.

  • Prepare submissions and oversee the maintenance of regulatory filings to support multinational trials (i.e., INDs, CTAs, amendments, safety updates, and Annual Reports)
  • Review clinical trial documents including clinical protocols/reports, investigator brochures and, nonclinical reports
  • Assist in the preparation and review of regulatory filings to support U.S. and international marketing applications, applications under review by health agencies, and post-approval products (i.e., NDAs, supplements, MAAs, variations, Annual Reports)
  • Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input
  • With some supervision, liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests
  • Lead the preparation of submissions, which may include INDs, CTAs, and briefing documents
  • With some supervision lead global regulatory activities for PIP/pediatric plans, Orphan Drug applications, Break Through designations
  • Coordinate with cross-functional teams to define contributions to submissions
  • Interface with international affiliates on regional regulatory strategy and implementation plans
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures
  • Conduct business development efforts, if assigned
  • Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs skill group
  • May be responsible to review and approve timesheets and expense reports and to guide the performance of assigned staff

You’ll need:

  • Bachelor’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD preferred
  • 8+ years’ experience in a CRO, pharmaceutical, biotechnology or device/diagnostics industry, an advanced degree will be considered in lieu of a portion of industry experience
  • 5-6 years progressive regulatory affairs experience in a CRO, pharmaceutical, biotechnology, or device/diagnostics company
  • 2-3 years supervisory/management experience preferred
  • Regional regulatory experience required; global experience preferred
  • Knowledge of regulatory requirements, including ICH and FDA
  • Demonstrated experience in preparation and maintenance of INDs and support of NDAs and/or BLAs
  • Knowledge of the drug development process with experience in multiple phases (early and late, post-approval) for various therapeutic areas
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
  • Ability to communicate and interact effectively within department, across departments and on project team(s)